Aortic Stenosis, Aortic Valve Insufficiency, Heart Failure, Mitral Stenosis, Mitral Valve Insufficiency
Conditions
Keywords
Aortic valve replacement, Mitral valve replacement
Brief summary
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.
Detailed description
Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and assessed after implant for up to 5 years.
Interventions
DEVICEEdwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria: Inclusion Criteria: 1. Is 18 years or older 2. Provides written informed consent prior to trial procedures 3. Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the COMMENCE trial and/or obtain the protocol-specified diagnostic tests at centers that are under the same IRB or the same healthcare system 4. Diagnosed with aortic or mitral valve disease requiring valve replacement based on pre- operative evaluation 5. Scheduled to undergo planned aortic or mitral valve replacement with or without concomitant bypass surgery 6. Scheduled to undergo planned aortic valve replacement with or without resection and replacement of the ascending aorta from the sinotubular junction and without the need for circulatory arrest for hemi arch or arch replacement
Exclusion criteria
A subject meeting any of the following criteria shall be excluded: 1. Requires emergency surgery 2. Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve repair) 3. Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ 4. Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass) 5. Requires surgical replacement of the aortic root 6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic or mitral valve replacement surgery 7. Has renal insufficiency as determined by creatinine (S-Cr) level ≥ 2.5 mg/dL or end -stage renal disease requiring chronic dialysis at screening visit 8. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to planned valve surgery 9. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery 10. Has presence of non-cardiac disease limiting life expectancy to less than 12 months 11. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM) 12. Diagnosed with abnormal calcium metabolism and hyperparathyroidism 13. Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure prior to planned valve surgery 14. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation 15. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery 16. Documented leukopenia (WBC \< 3.5x 10³/μL), acute anemia (Hgb \< 10.0 gm/dL or 6 mmol/L) or thrombocytopenia (platelet count \< 50x 10³/μL) accompanied by history of bleeding diathesis and coagulopathy 17. Has prior organ transplant or is currently an organ transplant candidate 18. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial 19. Was previously implanted with trial device (Model 11000A or Model 11000M) 20. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial 21. Currently incarcerated or unable to give voluntary informed consent 22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant 23. Requires concomitant left ventricular assist device (LVAD) placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Structural Valve Deterioration | 1 Year Post Implant | The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Early Adverse Events | Events occuring within 30 days of procedure | Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100 |
| Percentage of Late Adverse Events Divided by Late Patient Years | Events occurring >= 31 days and up through 3 years post-implant | Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). |
Countries
Canada, Poland, United States
Contacts
PRINCIPAL_INVESTIGATORJohn Puskas, MD
Icahn School of Medicine at Mount Sinai
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | 694 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | 83 |
| Total | 777 |
Baseline characteristics
| Characteristic | Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Total | Edwards Pericardial Aortic Bioprosthesis, Model 11000A |
|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 9.3 | 67.2 years STANDARD_DEVIATION 11.4 | 67 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 25 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 43 Participants | 37 Participants |
| Race (NIH/OMB) White | 73 Participants | 695 Participants | 622 Participants |
| Sex: Female, Male Female | 49 Participants | 245 Participants | 196 Participants |
| Sex: Female, Male Male | 34 Participants | 532 Participants | 498 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 26 / 689 | 8 / 82 |
| other Total, other adverse events | 542 / 589 | 66 / 82 |
| serious Total, serious adverse events | 317 / 689 | 58 / 82 |
Outcome results
Primary
Subjects With Structural Valve Deterioration
The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.
Time frame: 1 Year Post Implant
Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. The SVD result combines the aortic and mitral implanted subjects. The study was powered for the combined cohort for this endpoint as there would be too few mitral subjects to report the arms separately.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subjects With Structural Valve Deterioration | 1 Participants |
Comparison: The null hypothesis is that the rate of structural valve deterioration at one year is greater than 1%. The alternative hypothesis is that this rate is less than 1%.
Secondary
Percentage of Late Adverse Events Divided by Late Patient Years
Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Time frame: Events occurring >= 31 days and up through 3 years post-implant
Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Thromboembolism | 2.1 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Hemolysis | 0.0 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | All Bleeding | 2.6 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | All Paravalvular Leak (OPC) | 0.2 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Trial Valve Related Mortality | 0.7 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Major Paravalvular Leak (OPC) | 0.1 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Major Bleeding | 1.4 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Non-structural Valve Dysfunction | 0.0 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Valve Thrombosis | 0.0 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Reoperation | 0.2 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Endocarditis | 0.6 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Explant | 0.2 percentage of events/late patient years |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | All Cause Mortality | 2.2 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Explant | 1.7 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | All Cause Mortality | 6.1 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Trial Valve Related Mortality | 0.9 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Thromboembolism | 1.7 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Valve Thrombosis | 0.0 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | All Bleeding | 8.7 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Major Bleeding | 5.2 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Endocarditis | 0.9 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Hemolysis | 0.0 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | All Paravalvular Leak (OPC) | 0.0 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Major Paravalvular Leak (OPC) | 0.0 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Non-structural Valve Dysfunction | 0.9 percentage of events/late patient years |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Late Adverse Events Divided by Late Patient Years | Reoperation | 2.6 percentage of events/late patient years |
Secondary
Percentage of Subjects With Early Adverse Events
Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Time frame: Events occuring within 30 days of procedure
Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | Valve Thrombosis | 0.0 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | Hemolysis | 0.0 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | All Cause Mortality | 1.2 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | All Paravalvular Leak (OPC) | 0.3 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | All Bleeding | 0.9 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | Major Paravalvular Leak (OPC) | 0.1 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | Thromboembolism | 2.2 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | Non-structural Valve Dysfunction | 0.0 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | Major Bleeding | 0.7 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | Reoperation | 0.1 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | Trial Valve Related Mortality | 0.4 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | Explant | 0.0 percentage of subjects |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Percentage of Subjects With Early Adverse Events | Endocarditis | 0.0 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | Explant | 0.0 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | Trial Valve Related Mortality | 1.2 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | Thromboembolism | 2.4 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | Valve Thrombosis | 0.0 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | All Bleeding | 1.2 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | Major Bleeding | 1.2 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | Endocarditis | 0.0 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | Hemolysis | 0.0 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | All Paravalvular Leak (OPC) | 0.0 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | Major Paravalvular Leak (OPC) | 0.0 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | Non-structural Valve Dysfunction | 0.0 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | Reoperation | 0.0 percentage of subjects |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Percentage of Subjects With Early Adverse Events | All Cause Mortality | 1.2 percentage of subjects |
Other Pre-specified
Subject's Amount of Paravalvular Leak Over Time - 11000A
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000A device where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +2 Mild | 1 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | 0 None | 12 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +2 Mild | 2 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | 0 None | 20 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | 0 None | 6 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +1 Trivial/Trace | 1 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | 0 None | 92 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +1 Trivial/Trace | 1 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +2 Mild | 3 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | 0 None | 118 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | 0 None | 37 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +1 Trivial/Trace | 1 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +2 Mild | 4 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | 0 None | 61 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +1 Trivial/Trace | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +2 Mild | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | 0 None | 152 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +1 Trivial/Trace | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +2 Mild | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | 0 None | 191 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | 0 None | 127 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +2 Mild | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +2 Mild | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +2 Mild | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +1 Trivial/Trace | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | 0 None | 46 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | 0 None | 182 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +1 Trivial/Trace | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | 0 None | 87 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +2 Mild | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | 0 None | 67 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +2 Mild | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | 0 None | 16 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | 0 None | 12 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +1 Trivial/Trace | 6 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +2 Mild | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +1 Trivial/Trace | 7 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | +2 Mild | 9 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | 0 None | 610 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +1 Trivial/Trace | 8 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | +2 Mild | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 2 Year | 0 None | 166 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 1 Year | 0 None | 450 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Paravalvular Leak Over Time - 11000A | 3 Months | +3 Moderate | 1 Participants |
Other Pre-specified
Subject's Amount of Paravalvular Leak Over Time - 11000M
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000M device where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | 0 None | 5 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | 0 None | 4 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | 0 None | 26 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | 0 None | 13 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | 0 None | 25 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | 0 None | 21 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | 0 None | 23 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | 0 None | 7 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | 0 None | 15 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | 0 None | 11 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | 0 None | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | 0 None | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | 0 None | 6 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | 0 None | 6 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | 0 None | 24 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | 0 None | 75 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 3 Months | +1 Trivial/Trace | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Paravalvular Leak Over Time - 11000M | 1 Year | 0 None | 67 Participants |
Other Pre-specified
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A
Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000A device where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | 0 None | 11 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +2 Mild | 2 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | 0 None | 17 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +1 Trivial/Trace | 3 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | 0 None | 4 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +2 Mild | 2 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +1 Trivial/Trace | 3 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +2 Mild | 1 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +1 Trivial/Trace | 5 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | 0 None | 106 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +1 Trivial/Trace | 11 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +2 Mild | 1 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | 0 None | 88 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +1 Trivial/Trace | 6 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +2 Mild | 2 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +3 Moderate | 1 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | 0 None | 32 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +2 Mild | 5 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +1 Trivial/Trace | 25 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | 0 None | 166 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +2 Mild | 8 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +2 Mild | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | 0 None | 125 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +4 Severe | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +1 Trivial/Trace | 11 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | 0 None | 51 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +1 Trivial/Trace | 26 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +2 Mild | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | 0 None | 112 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +1 Trivial/Trace | 12 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +2 Mild | 7 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +1 Trivial/Trace | 20 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | 0 None | 38 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +1 Trivial/Trace | 9 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +2 Mild | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | 0 None | 162 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +2 Mild | 4 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +1 Trivial/Trace | 17 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | 0 None | 11 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +1 Trivial/Trace | 5 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | 0 None | 69 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | 0 None | 49 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +2 Mild | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +2 Mild | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +1 Trivial/Trace | 20 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +2 Mild | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +1 Trivial/Trace | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | 0 None | 11 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +1 Trivial/Trace | 64 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +2 Mild | 14 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +1 Trivial/Trace | 80 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +2 Mild | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | 0 None | 136 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | 0 None | 531 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | 0 None | 385 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +2 Mild | 21 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 1 Year | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +1 Trivial/Trace | 32 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 2 Year | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A | 3 Months | +4 Severe | 1 Participants |
Other Pre-specified
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M
Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000M device where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +1 Trivial/Trace | 1 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | 0 None | 3 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +1 Trivial/Trace | 1 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | 0 None | 4 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | 0 None | 6 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +3 Moderate | 1 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +2 Mild | 3 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +1 Trivial/Trace | 5 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +3 Moderate | 1 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +3 Moderate | 1 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | 0 None | 15 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +2 Mild | 4 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +2 Mild | 4 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +1 Trivial/Trace | 7 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | 0 None | 15 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | 0 None | 18 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +1 Trivial/Trace | 5 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | 0 None | 13 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +1 Trivial/Trace | 7 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | 0 None | 6 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +1 Trivial/Trace | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +1 Trivial/Trace | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +4 Severe | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +1 Trivial/Trace | 4 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +1 Trivial/Trace | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | 0 None | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | 0 None | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | 0 None | 8 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +2 Mild | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | 0 None | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +2 Mild | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +3 Moderate | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | 0 None | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +2 Mild | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | 0 None | 4 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +1 Trivial/Trace | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | 0 None | 51 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +1 Trivial/Trace | 18 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +3 Moderate | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | 0 None | 42 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +2 Mild | 4 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +2 Mild | 5 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 3 Months | +2 Mild | 5 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | 0 None | 13 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +4 Severe | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +4 Severe | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +3 Moderate | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 1 Year | +1 Trivial/Trace | 19 Participants |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M | 2 Year | +1 Trivial/Trace | 6 Participants |
Other Pre-specified
Subject's Average Cardiac Index Over Time- 11000A
Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000A device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Cardiac Index Over Time- 11000A | 1 Year | 2.6 L/min/m^2 | Standard Deviation 0.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Cardiac Index Over Time- 11000A | 2 Year | 2.2 L/min/m^2 | Standard Deviation 0.8 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Cardiac Index Over Time- 11000A | 3 Months | 3.0 L/min/m^2 | Standard Deviation 0.8 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Index Over Time- 11000A | 1 Year | 2.5 L/min/m^2 | Standard Deviation 1 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Index Over Time- 11000A | 3 Months | 2.4 L/min/m^2 | Standard Deviation 0.7 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Index Over Time- 11000A | 2 Year | 2.3 L/min/m^2 | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Index Over Time- 11000A | 1 Year | 2.2 L/min/m^2 | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Index Over Time- 11000A | 3 Months | 2.4 L/min/m^2 | Standard Deviation 0.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Index Over Time- 11000A | 2 Year | 2.2 L/min/m^2 | Standard Deviation 0.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Index Over Time- 11000A | 2 Year | 2.3 L/min/m^2 | Standard Deviation 0.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Index Over Time- 11000A | 1 Year | 2.2 L/min/m^2 | Standard Deviation 0.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Index Over Time- 11000A | 3 Months | 2.3 L/min/m^2 | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Index Over Time- 11000A | 1 Year | 2.4 L/min/m^2 | Standard Deviation 0.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Index Over Time- 11000A | 2 Year | 2.0 L/min/m^2 | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Index Over Time- 11000A | 3 Months | 2.4 L/min/m^2 | Standard Deviation 0.9 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Cardiac Index Over Time- 11000A | 3 Months | 2.0 L/min/m^2 | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Cardiac Index Over Time- 11000A | 2 Year | 2.2 L/min/m^2 | Standard Deviation 0.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Cardiac Index Over Time- 11000A | 1 Year | 2.3 L/min/m^2 | Standard Deviation 0.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Cardiac Index Over Time- 11000A | 3 Months | 2.4 L/min/m^2 | Standard Deviation 0.7 |
Other Pre-specified
Subject's Average Cardiac Index Over Time - 11000M
Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area(BSA), thus relating heart performance to the size of the individual.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Cardiac Index Over Time - 11000M | 1 Year | 2.0 L/min/m^2 | Standard Deviation 0.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Cardiac Index Over Time - 11000M | 3 Months | 2.2 L/min/m^2 | Standard Deviation 0.7 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Index Over Time - 11000M | 1 Year | 1.9 L/min/m^2 | Standard Deviation 0.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Index Over Time - 11000M | 3 Months | 2.1 L/min/m^2 | Standard Deviation 0.6 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Index Over Time - 11000M | 2 Year | 1.9 L/min/m^2 | Standard Deviation 0.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Index Over Time - 11000M | 1 Year | 2.2 L/min/m^2 | Standard Deviation 0.9 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Index Over Time - 11000M | 3 Months | 2.2 L/min/m^2 | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Index Over Time - 11000M | 2 Year | 2.1 L/min/m^2 | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Index Over Time - 11000M | 2 Year | 1.9 L/min/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Index Over Time - 11000M | 3 Months | 1.9 L/min/m^2 | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Index Over Time - 11000M | 1 Year | 1.9 L/min/m^2 | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Index Over Time - 11000M | 3 Months | 2.1 L/min/m^2 | Standard Deviation 0.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Index Over Time - 11000M | 1 Year | 1.8 L/min/m^2 | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Index Over Time - 11000M | 2 Year | 1.6 L/min/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Cardiac Index Over Time - 11000M | 1 Year | 2.0 L/min/m^2 | Standard Deviation 0.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Cardiac Index Over Time - 11000M | 3 Months | 2.1 L/min/m^2 | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Cardiac Index Over Time - 11000M | 2 Year | 1.9 L/min/m^2 | Standard Deviation 0.6 |
Other Pre-specified
Subject's Average Cardiac Output Over Time - 11000A
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000A device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Cardiac Output Over Time - 11000A | 3 Months | 5.1 Liters/minute | Standard Deviation 1.3 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Cardiac Output Over Time - 11000A | 1 Year | 4.5 Liters/minute | Standard Deviation 0.9 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Cardiac Output Over Time - 11000A | 2 Year | 3.7 Liters/minute | Standard Deviation 1.1 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Output Over Time - 11000A | 1 Year | 4.7 Liters/minute | Standard Deviation 1.8 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Output Over Time - 11000A | 3 Months | 4.5 Liters/minute | Standard Deviation 1.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Output Over Time - 11000A | 2 Year | 4.3 Liters/minute | Standard Deviation 1.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Output Over Time - 11000A | 2 Year | 4.4 Liters/minute | Standard Deviation 1.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Output Over Time - 11000A | 3 Months | 4.7 Liters/minute | Standard Deviation 1.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Output Over Time - 11000A | 1 Year | 4.4 Liters/minute | Standard Deviation 1.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Output Over Time - 11000A | 3 Months | 4.8 Liters/minute | Standard Deviation 1.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Output Over Time - 11000A | 2 Year | 4.9 Liters/minute | Standard Deviation 1.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Output Over Time - 11000A | 1 Year | 4.8 Liters/minute | Standard Deviation 1.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Output Over Time - 11000A | 3 Months | 5.2 Liters/minute | Standard Deviation 1.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Output Over Time - 11000A | 1 Year | 5.4 Liters/minute | Standard Deviation 1.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Output Over Time - 11000A | 2 Year | 4.4 Liters/minute | Standard Deviation 1.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Cardiac Output Over Time - 11000A | 3 Months | 4.4 Liters/minute | Standard Deviation 1.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Cardiac Output Over Time - 11000A | 2 Year | 4.5 Liters/minute | Standard Deviation 1.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Cardiac Output Over Time - 11000A | 3 Months | 4.8 Liters/minute | Standard Deviation 1.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Cardiac Output Over Time - 11000A | 1 Year | 4.7 Liters/minute | Standard Deviation 1.6 |
Other Pre-specified
Subject's Average Cardiac Output Over Time - 11000M
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Cardiac Output Over Time - 11000M | 1 Year | 3.7 Liters/Minute | Standard Deviation 1 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Cardiac Output Over Time - 11000M | 3 Months | 4.0 Liters/Minute | Standard Deviation 1.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Output Over Time - 11000M | 1 Year | 3.3 Liters/Minute | Standard Deviation 1.1 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Output Over Time - 11000M | 3 Months | 3.6 Liters/Minute | Standard Deviation 0.9 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Cardiac Output Over Time - 11000M | 2 Year | 3.3 Liters/Minute | Standard Deviation 1.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Output Over Time - 11000M | 1 Year | 4.4 Liters/Minute | Standard Deviation 1.9 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Output Over Time - 11000M | 3 Months | 4.3 Liters/Minute | Standard Deviation 1.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Cardiac Output Over Time - 11000M | 2 Year | 4.1 Liters/Minute | Standard Deviation 1.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Output Over Time - 11000M | 2 Year | 3.6 Liters/Minute | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Output Over Time - 11000M | 3 Months | 3.9 Liters/Minute | Standard Deviation 0.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Cardiac Output Over Time - 11000M | 1 Year | 3.8 Liters/Minute | Standard Deviation 1.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Output Over Time - 11000M | 3 Months | 4.6 Liters/Minute | Standard Deviation 1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Output Over Time - 11000M | 1 Year | 3.8 Liters/Minute | Standard Deviation 0.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Cardiac Output Over Time - 11000M | 2 Year | 3.3 Liters/Minute | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Cardiac Output Over Time - 11000M | 1 Year | 3.8 Liters/Minute | Standard Deviation 1.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Cardiac Output Over Time - 11000M | 3 Months | 4.0 Liters/Minute | Standard Deviation 1.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Cardiac Output Over Time - 11000M | 2 Year | 3.6 Liters/Minute | Standard Deviation 1.1 |
Other Pre-specified
Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000A device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 1 Year | 0.6 cm^2/m^2 | Standard Deviation 0.1 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 2 Year | 0.6 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 3 Months | 0.8 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 1 Year | 0.7 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 3 Months | 0.8 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 2 Year | 0.7 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 1 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 3 Months | 0.9 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 2 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 2 Year | 0.9 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 1 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 3 Months | 0.9 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 1 Year | 1.0 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 2 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 3 Months | 1.1 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 3 Months | 1.1 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 2 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 1 Year | 0.8 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A | 3 Months | 0.9 cm^2/m^2 | Standard Deviation 0.3 |
Other Pre-specified
Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 1 Year | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 3 Months | 0.7 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 1 Year | 0.7 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 3 Months | 0.8 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 2 Year | 0.8 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 1 Year | 0.8 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 3 Months | 0.8 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 2 Year | 0.7 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 2 Year | 0.9 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 3 Months | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 1 Year | 0.7 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 3 Months | 0.9 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 1 Year | 0.7 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 2 Year | 0.6 cm^2/m^2 | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 1 Year | 0.7 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 3 Months | 0.8 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M | 2 Year | 0.7 cm^2/m^2 | Standard Deviation 0.3 |
Other Pre-specified
Subject's Average Effective Orifice Area Measurements - 11000A
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000A device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Effective Orifice Area Measurements - 11000A | 1 Year | 1.1 Centimeters Squared | Standard Deviation 0.2 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Effective Orifice Area Measurements - 11000A | 2 Year | 1.0 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Effective Orifice Area Measurements - 11000A | 3 Months | 1.4 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Measurements - 11000A | 1 Year | 1.3 Centimeters Squared | Standard Deviation 0.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Measurements - 11000A | 3 Months | 1.5 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Measurements - 11000A | 2 Year | 1.3 Centimeters Squared | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Measurements - 11000A | 1 Year | 1.6 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Measurements - 11000A | 3 Months | 1.7 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Measurements - 11000A | 2 Year | 1.6 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Measurements - 11000A | 2 Year | 1.9 Centimeters Squared | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Measurements - 11000A | 1 Year | 1.8 Centimeters Squared | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Measurements - 11000A | 3 Months | 1.8 Centimeters Squared | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Measurements - 11000A | 1 Year | 2.2 Centimeters Squared | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Measurements - 11000A | 2 Year | 1.8 Centimeters Squared | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Measurements - 11000A | 3 Months | 2.3 Centimeters Squared | Standard Deviation 0.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Effective Orifice Area Measurements - 11000A | 3 Months | 2.5 Centimeters Squared | Standard Deviation 0.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Effective Orifice Area Measurements - 11000A | 2 Year | 1.6 Centimeters Squared | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Effective Orifice Area Measurements - 11000A | 1 Year | 1.7 Centimeters Squared | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Effective Orifice Area Measurements - 11000A | 3 Months | 1.8 Centimeters Squared | Standard Deviation 0.6 |
Other Pre-specified
Subject's Average Effective Orifice Area Measurements - 11000M
Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Effective Orifice Area Measurements - 11000M | 1 Year | 1.1 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Effective Orifice Area Measurements - 11000M | 3 Months | 1.2 Centimeters Squared | Standard Deviation 0.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Measurements - 11000M | 1 Year | 1.2 Centimeters Squared | Standard Deviation 0.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Measurements - 11000M | 3 Months | 1.4 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Effective Orifice Area Measurements - 11000M | 2 Year | 1.3 Centimeters Squared | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Measurements - 11000M | 1 Year | 1.5 Centimeters Squared | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Measurements - 11000M | 3 Months | 1.6 Centimeters Squared | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Effective Orifice Area Measurements - 11000M | 2 Year | 1.4 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Measurements - 11000M | 2 Year | 1.6 Centimeters Squared | Standard Deviation 0 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Measurements - 11000M | 3 Months | 1.6 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Effective Orifice Area Measurements - 11000M | 1 Year | 1.4 Centimeters Squared | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Measurements - 11000M | 3 Months | 1.8 Centimeters Squared | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Measurements - 11000M | 1 Year | 1.5 Centimeters Squared | Standard Deviation 0.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Effective Orifice Area Measurements - 11000M | 2 Year | 1.2 Centimeters Squared | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Effective Orifice Area Measurements - 11000M | 1 Year | 1.4 Centimeters Squared | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Effective Orifice Area Measurements - 11000M | 3 Months | 1.5 Centimeters Squared | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Effective Orifice Area Measurements - 11000M | 2 Year | 1.4 Centimeters Squared | Standard Deviation 0.4 |
Other Pre-specified
Subject's Average Hematocrit Percentage
Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood).
Time frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Hematocrit Percentage | Discharge | 30.1 percentage of red blood cells | Standard Deviation 4.1 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Hematocrit Percentage | 1 Year | 41.9 percentage of red blood cells | Standard Deviation 4.1 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Hematocrit Percentage | 3 Months | 41.0 percentage of red blood cells | Standard Deviation 4.2 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Hematocrit Percentage | 2 Year | 42.0 percentage of red blood cells | Standard Deviation 3.9 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Hematocrit Percentage | Baseline | 41.0 percentage of red blood cells | Standard Deviation 4 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Hematocrit Percentage | 2 Year | 42.4 percentage of red blood cells | Standard Deviation 4.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Hematocrit Percentage | Baseline | 40.3 percentage of red blood cells | Standard Deviation 4.6 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Hematocrit Percentage | Discharge | 30.1 percentage of red blood cells | Standard Deviation 3.9 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Hematocrit Percentage | 3 Months | 39.3 percentage of red blood cells | Standard Deviation 5.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Hematocrit Percentage | 1 Year | 41.3 percentage of red blood cells | Standard Deviation 4.8 |
Other Pre-specified
Subject's Average Hemoglobin Count
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Time frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Hemoglobin Count | Discharge | 10.0 g/dl | Standard Deviation 1.4 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Hemoglobin Count | 1 Year | 14.0 g/dl | Standard Deviation 1.7 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Hemoglobin Count | 3 Months | 13.5 g/dl | Standard Deviation 1.6 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Hemoglobin Count | 2 Year | 14.0 g/dl | Standard Deviation 1.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Hemoglobin Count | Baseline | 13.8 g/dl | Standard Deviation 1.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Hemoglobin Count | 2 Year | 14.0 g/dl | Standard Deviation 1.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Hemoglobin Count | Baseline | 13.3 g/dl | Standard Deviation 1.6 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Hemoglobin Count | Discharge | 9.9 g/dl | Standard Deviation 1.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Hemoglobin Count | 3 Months | 12.7 g/dl | Standard Deviation 1.9 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Hemoglobin Count | 1 Year | 13.6 g/dl | Standard Deviation 1.6 |
Other Pre-specified
Subject's Average International Normalized Ratio
Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot. INR results will vary according to a person's age, the medicines they take, and any health problems they may have. In general, the higher the INR number, the longer it takes for the blood to clot. In healthy people an INR of 1.1 or below is considered normal. An INR range of 2.0 to 3.0 is generally an effective therapeutic range for people taking blood thinner medication.
Time frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average International Normalized Ratio | Discharge | 1.3 Ratio | Standard Deviation 0.4 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average International Normalized Ratio | 1 Year | 1.2 Ratio | Standard Deviation 0.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average International Normalized Ratio | 3 Months | 1.3 Ratio | Standard Deviation 0.7 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average International Normalized Ratio | 2 Year | 1.2 Ratio | Standard Deviation 0.6 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average International Normalized Ratio | Baseline | 1.1 Ratio | Standard Deviation 0.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average International Normalized Ratio | 2 Year | 1.6 Ratio | Standard Deviation 0.8 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average International Normalized Ratio | Baseline | 1.4 Ratio | Standard Deviation 0.7 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average International Normalized Ratio | Discharge | 1.7 Ratio | Standard Deviation 0.6 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average International Normalized Ratio | 3 Months | 1.9 Ratio | Standard Deviation 0.8 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average International Normalized Ratio | 1 Year | 1.7 Ratio | Standard Deviation 0.8 |
Other Pre-specified
Subject's Average Mean Gradient Measurements - 11000A
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Time frame: 3 Months, 1 Year, and 2 Year Post Implant
Population: The outcome is reported for subjects who received the Model 11000A device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Mean Gradient Measurements - 11000A | 1 Year | 17.6 mmHg | Standard Deviation 7.8 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Mean Gradient Measurements - 11000A | 2 Year | 16.1 mmHg | Standard Deviation 6.4 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Mean Gradient Measurements - 11000A | 3 Months | 13.8 mmHg | Standard Deviation 6.1 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Mean Gradient Measurements - 11000A | 1 Year | 12.6 mmHg | Standard Deviation 4.7 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Mean Gradient Measurements - 11000A | 3 Months | 10.7 mmHg | Standard Deviation 4.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Mean Gradient Measurements - 11000A | 2 Year | 11.2 mmHg | Standard Deviation 4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Mean Gradient Measurements - 11000A | 1 Year | 10.1 mmHg | Standard Deviation 3.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Mean Gradient Measurements - 11000A | 3 Months | 9.4 mmHg | Standard Deviation 3.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Mean Gradient Measurements - 11000A | 2 Year | 9.9 mmHg | Standard Deviation 4.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Mean Gradient Measurements - 11000A | 2 Year | 9.2 mmHg | Standard Deviation 3.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Mean Gradient Measurements - 11000A | 1 Year | 9.6 mmHg | Standard Deviation 5.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Mean Gradient Measurements - 11000A | 3 Months | 8.7 mmHg | Standard Deviation 3.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Mean Gradient Measurements - 11000A | 1 Year | 8.2 mmHg | Standard Deviation 3.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Mean Gradient Measurements - 11000A | 2 Year | 8.3 mmHg | Standard Deviation 3.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Mean Gradient Measurements - 11000A | 3 Months | 6.8 mmHg | Standard Deviation 2.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Mean Gradient Measurements - 11000A | 3 Months | 4.7 mmHg | Standard Deviation 1.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Mean Gradient Measurements - 11000A | 2 Year | 10.1 mmHg | Standard Deviation 4.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Mean Gradient Measurements - 11000A | 1 Year | 10.4 mmHg | Standard Deviation 4.9 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Mean Gradient Measurements - 11000A | 3 Months | 9.1 mmHg | Standard Deviation 4 |
Other Pre-specified
Subject's Average Mean Gradient Measurements - 11000M
Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Mean Gradient Measurements - 11000M | 1 Year | 4.9 mmHg | Standard Deviation 1.2 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Mean Gradient Measurements - 11000M | 3 Months | 5.6 mmHg | Standard Deviation 0.7 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Mean Gradient Measurements - 11000M | 1 Year | 4.1 mmHg | Standard Deviation 1.4 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Mean Gradient Measurements - 11000M | 3 Months | 4.1 mmHg | Standard Deviation 1.7 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Mean Gradient Measurements - 11000M | 2 Year | 3.9 mmHg | Standard Deviation 1.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Mean Gradient Measurements - 11000M | 1 Year | 4.1 mmHg | Standard Deviation 1.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Mean Gradient Measurements - 11000M | 3 Months | 4.0 mmHg | Standard Deviation 1.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Mean Gradient Measurements - 11000M | 2 Year | 3.8 mmHg | Standard Deviation 1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Mean Gradient Measurements - 11000M | 2 Year | 3.5 mmHg | Standard Deviation 0.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Mean Gradient Measurements - 11000M | 3 Months | 3.4 mmHg | Standard Deviation 1.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Mean Gradient Measurements - 11000M | 1 Year | 3.9 mmHg | Standard Deviation 2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Mean Gradient Measurements - 11000M | 3 Months | 3.3 mmHg | Standard Deviation 1.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Mean Gradient Measurements - 11000M | 1 Year | 3.3 mmHg | Standard Deviation 1.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Mean Gradient Measurements - 11000M | 2 Year | 3.4 mmHg | Standard Deviation 2.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Mean Gradient Measurements - 11000M | 1 Year | 4.0 mmHg | Standard Deviation 1.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Mean Gradient Measurements - 11000M | 3 Months | 4.0 mmHg | Standard Deviation 1.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Mean Gradient Measurements - 11000M | 2 Year | 3.8 mmHg | Standard Deviation 1.5 |
Other Pre-specified
Subject's Average Partial Thromboplastin Time
Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot.
Time frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Partial Thromboplastin Time | Discharge | 32.1 Seconds | Standard Deviation 8.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Partial Thromboplastin Time | 1 Year | 29.4 Seconds | Standard Deviation 5.7 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Partial Thromboplastin Time | 3 Months | 31.2 Seconds | Standard Deviation 15.8 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Partial Thromboplastin Time | 2 Year | 31.4 Seconds | Standard Deviation 14.4 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Partial Thromboplastin Time | Baseline | 30.0 Seconds | Standard Deviation 6 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Partial Thromboplastin Time | 2 Year | 33.7 Seconds | Standard Deviation 9.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Partial Thromboplastin Time | Baseline | 35.1 Seconds | Standard Deviation 14.4 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Partial Thromboplastin Time | Discharge | 37.2 Seconds | Standard Deviation 14.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Partial Thromboplastin Time | 3 Months | 36.0 Seconds | Standard Deviation 8.1 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Partial Thromboplastin Time | 1 Year | 35.3 Seconds | Standard Deviation 14.3 |
Other Pre-specified
Subject's Average Peak Gradients Measurements Over Time - 11000A
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000A device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000A | 1 Year | 35.0 mmHg | Standard Deviation 16.3 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000A | 2 Year | 31.7 mmHg | Standard Deviation 12 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000A | 3 Month | 27.5 mmHg | Standard Deviation 12.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000A | 1 Year | 25.2 mmHg | Standard Deviation 8.9 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000A | 3 Month | 21.7 mmHg | Standard Deviation 8.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000A | 2 Year | 22.0 mmHg | Standard Deviation 7.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Peak Gradients Measurements Over Time - 11000A | 1 Year | 20.1 mmHg | Standard Deviation 7.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Peak Gradients Measurements Over Time - 11000A | 3 Month | 18.8 mmHg | Standard Deviation 6.9 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Peak Gradients Measurements Over Time - 11000A | 2 Year | 19.8 mmHg | Standard Deviation 8.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Peak Gradients Measurements Over Time - 11000A | 2 Year | 18.2 mmHg | Standard Deviation 6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Peak Gradients Measurements Over Time - 11000A | 1 Year | 19.2 mmHg | Standard Deviation 8.9 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Peak Gradients Measurements Over Time - 11000A | 3 Month | 17.5 mmHg | Standard Deviation 6.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Peak Gradients Measurements Over Time - 11000A | 1 Year | 16.7 mmHg | Standard Deviation 6.9 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Peak Gradients Measurements Over Time - 11000A | 2 Year | 16.4 mmHg | Standard Deviation 6.6 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Peak Gradients Measurements Over Time - 11000A | 3 Month | 13.8 mmHg | Standard Deviation 4.9 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Peak Gradients Measurements Over Time - 11000A | 3 Month | 10.1 mmHg | Standard Deviation 3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Peak Gradients Measurements Over Time - 11000A | 2 Year | 20.1 mmHg | Standard Deviation 8.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Peak Gradients Measurements Over Time - 11000A | 1 Year | 20.9 mmHg | Standard Deviation 9.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Peak Gradients Measurements Over Time - 11000A | 3 Month | 18.4 mmHg | Standard Deviation 7.6 |
Other Pre-specified
Subject's Average Peak Gradients Measurements Over Time - 11000M
Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000M | 1 Year | 10.6 mmHg | Standard Deviation 3 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000M | 3 Months | 12.0 mmHg | Standard Deviation 1.4 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000M | 1 Year | 9.9 mmHg | Standard Deviation 3.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000M | 3 Months | 9.8 mmHg | Standard Deviation 4 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Peak Gradients Measurements Over Time - 11000M | 2 Year | 9.5 mmHg | Standard Deviation 4.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 1 Year | 10.4 mmHg | Standard Deviation 3.7 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 3 Months | 10.2 mmHg | Standard Deviation 4.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 2 Year | 10.5 mmHg | Standard Deviation 3.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 2 Year | 6.6 mmHg | Standard Deviation 1.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 3 Months | 9.0 mmHg | Standard Deviation 2.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 1 Year | 10.2 mmHg | Standard Deviation 5.5 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 3 Months | 17.4 mmHg | Standard Deviation 22.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 1 Year | 9.0 mmHg | Standard Deviation 4.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 2 Year | 8.3 mmHg | Standard Deviation 3.4 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 1 Year | 10.1 mmHg | Standard Deviation 3.8 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 3 Months | 10.5 mmHg | Standard Deviation 7.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Peak Gradients Measurements Over Time - 11000M | 2 Year | 9.4 mmHg | Standard Deviation 4 |
Other Pre-specified
Subject's Average Performance Index Measurements - 11000A
Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000A device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Performance Index Measurements - 11000A | 1 Year | 0.9 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Performance Index Measurements - 11000A | 2 Year | 0.8 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Performance Index Measurements - 11000A | 3 Months | 1.1 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Performance Index Measurements - 11000A | 1 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Performance Index Measurements - 11000A | 3 Months | 0.9 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Performance Index Measurements - 11000A | 2 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Performance Index Measurements - 11000A | 1 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Performance Index Measurements - 11000A | 3 Months | 0.9 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Performance Index Measurements - 11000A | 2 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Performance Index Measurements - 11000A | 2 Year | 0.9 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Performance Index Measurements - 11000A | 1 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Performance Index Measurements - 11000A | 3 Months | 0.9 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Performance Index Measurements - 11000A | 1 Year | 0.9 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Performance Index Measurements - 11000A | 2 Year | 0.7 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Performance Index Measurements - 11000A | 3 Months | 0.9 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Performance Index Measurements - 11000A | 3 Months | 0.8 cm^2/m^2 | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Performance Index Measurements - 11000A | 2 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Performance Index Measurements - 11000A | 1 Year | 0.8 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total | Subject's Average Performance Index Measurements - 11000A | 3 Months | 0.9 cm^2/m^2 | Standard Deviation 0.2 |
Other Pre-specified
Subject's Average Performance Index Measurements - 11000M
Performance index is defined as the subject's effective orifice area (the crosssectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Performance Index Measurements - 11000M | 1 Year | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Performance Index Measurements - 11000M | 3 Months | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Performance Index Measurements - 11000M | 2 Year | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Performance Index Measurements - 11000M | 1 Year | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Performance Index Measurements - 11000M | 3 Months | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Performance Index Measurements - 11000M | 2 Year | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Performance Index Measurements - 11000M | 3 Months | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Subject's Average Performance Index Measurements - 11000M | 1 Year | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Performance Index Measurements - 11000M | 3 Months | 0.5 cm^2/m^2 | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Performance Index Measurements - 11000M | 1 Year | 0.5 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Subject's Average Performance Index Measurements - 11000M | 2 Year | 0.6 cm^2/m^2 | Standard Deviation 0 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Performance Index Measurements - 11000M | 3 Months | 0.6 cm^2/m^2 | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Performance Index Measurements - 11000M | 2 Year | 0.4 cm^2/m^2 | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Subject's Average Performance Index Measurements - 11000M | 1 Year | 0.5 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Performance Index Measurements - 11000M | 1 Year | 0.5 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Performance Index Measurements - 11000M | 3 Months | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Subject's Average Performance Index Measurements - 11000M | 2 Year | 0.6 cm^2/m^2 | Standard Deviation 0.2 |
Other Pre-specified
Subject's Average Plasma Free Hemoglobin
Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood).
Time frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Plasma Free Hemoglobin | Discharge | 7.3 mg/dl | Standard Deviation 12.2 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Plasma Free Hemoglobin | 1 Year | 13.8 mg/dl | Standard Deviation 25.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Plasma Free Hemoglobin | 3 Months | 12.4 mg/dl | Standard Deviation 22.2 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Plasma Free Hemoglobin | 2 Year | 17.3 mg/dl | Standard Deviation 33.9 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Plasma Free Hemoglobin | Baseline | 11.6 mg/dl | Standard Deviation 18.4 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Plasma Free Hemoglobin | 2 Year | 20.5 mg/dl | Standard Deviation 33.9 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Plasma Free Hemoglobin | Baseline | 19.8 mg/dl | Standard Deviation 32.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Plasma Free Hemoglobin | Discharge | 7.2 mg/dl | Standard Deviation 6.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Plasma Free Hemoglobin | 3 Months | 10.6 mg/dl | Standard Deviation 12.1 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Plasma Free Hemoglobin | 1 Year | 8.6 mg/dl | Standard Deviation 12.3 |
Other Pre-specified
Subject's Average Platelet Count
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Time frame: Baseline, Discharge, 3 Months, 1 Year, and 2 Years
Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Platelet Count | Discharge | 217.7 10^3 platelets per microliter | Standard Deviation 90.1 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Platelet Count | 1 Year | 207.7 10^3 platelets per microliter | Standard Deviation 65.8 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Platelet Count | 3 Months | 215.3 10^3 platelets per microliter | Standard Deviation 62.6 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Platelet Count | 2 Year | 200.6 10^3 platelets per microliter | Standard Deviation 54.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Platelet Count | Baseline | 208.6 10^3 platelets per microliter | Standard Deviation 59 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Platelet Count | 2 Year | 204.0 10^3 platelets per microliter | Standard Deviation 54.1 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Platelet Count | Baseline | 203.6 10^3 platelets per microliter | Standard Deviation 52.1 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Platelet Count | Discharge | 196.0 10^3 platelets per microliter | Standard Deviation 75.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Platelet Count | 3 Months | 221.0 10^3 platelets per microliter | Standard Deviation 71.8 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Platelet Count | 1 Year | 207.8 10^3 platelets per microliter | Standard Deviation 51.7 |
Other Pre-specified
Subject's Average Prothrombin Time
Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot.
Time frame: Baseline, Discharge, 3 Months, 1 Year, and 2 Years
Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Prothrombin Time | 3 Months | 15.2 Seconds | Standard Deviation 7.4 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Prothrombin Time | Discharge | 15.0 Seconds | Standard Deviation 5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Prothrombin Time | 1 Year | 13.8 Seconds | Standard Deviation 5.7 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Prothrombin Time | 2 Year | 14.1 Seconds | Standard Deviation 6.4 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Prothrombin Time | Baseline | 12.7 Seconds | Standard Deviation 2.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Prothrombin Time | 2 Year | 17.3 Seconds | Standard Deviation 7.9 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Prothrombin Time | Baseline | 16.2 Seconds | Standard Deviation 8 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Prothrombin Time | Discharge | 20.1 Seconds | Standard Deviation 7.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Prothrombin Time | 3 Months | 21.0 Seconds | Standard Deviation 8.4 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Prothrombin Time | 1 Year | 19.1 Seconds | Standard Deviation 8.8 |
Other Pre-specified
Subject's Average Red Blood Cells Count
Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.
Time frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Red Blood Cells Count | 2 Year | 4.6 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Red Blood Cells Count | Baseline | 4.5 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Red Blood Cells Count | Discharge | 3.3 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Red Blood Cells Count | 3 Months | 4.7 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Red Blood Cells Count | 1 Year | 4.7 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Red Blood Cells Count | 1 Year | 4.5 10^6 cells/microliters | Standard Deviation 0.6 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Red Blood Cells Count | 3 Months | 4.5 10^6 cells/microliters | Standard Deviation 0.7 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Red Blood Cells Count | Baseline | 4.4 10^6 cells/microliters | Standard Deviation 0.6 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Red Blood Cells Count | 2 Year | 4.6 10^6 cells/microliters | Standard Deviation 0.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Red Blood Cells Count | Discharge | 3.3 10^6 cells/microliters | Standard Deviation 0.4 |
Other Pre-specified
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.
Time frame: Baseline and one year post-implant
Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Physical Health-Baseline | 42.9 units on a scale | Standard Deviation 9.7 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Physical Health-1 Year | 49.1 units on a scale | Standard Deviation 9.2 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Mental Health-Baseline | 50.9 units on a scale | Standard Deviation 9.5 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Mental Health-1 Year | 53.8 units on a scale | Standard Deviation 8.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Mental Health-1 Year | 52.3 units on a scale | Standard Deviation 9.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Physical Health-Baseline | 40.1 units on a scale | Standard Deviation 8.9 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Mental Health-Baseline | 49.2 units on a scale | Standard Deviation 11.5 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | Physical Health-1 Year | 48.8 units on a scale | Standard Deviation 7 |
Other Pre-specified
Subjects Average Serum Glycerol Levels
Laboratory analysis of serum glycerol in blood drawn from subjects. This blood test measures the amount of glycerol (a naturally occurring carbohydrate, that can be used as a fuel source by the body) in the serum (liquid portion of the blood).
Time frame: Pre-Implant (post-heparinization) and Post-Implant (between 60 and 120 minutes after heart was restarted)
Population: The outcome is reported for subjects who received the Model 11000A device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subjects Average Serum Glycerol Levels | Pre-Implant | 405.4 micromol/L | Standard Deviation 270.2 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subjects Average Serum Glycerol Levels | Post-Implant | 245.6 micromol/L | Standard Deviation 345.8 |
Other Pre-specified
Subject's Average White Blood Cell Count
Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection.
Time frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average White Blood Cell Count | Baseline | 7.2 10^3 cells /microliter | Standard Deviation 1.9 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average White Blood Cell Count | 1 Year | 7.3 10^3 cells /microliter | Standard Deviation 1.9 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average White Blood Cell Count | 3 Months | 7.1 10^3 cells /microliter | Standard Deviation 1.7 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average White Blood Cell Count | 2 Year | 7.3 10^3 cells /microliter | Standard Deviation 1.8 |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's Average White Blood Cell Count | Discharge | 9.1 10^3 cells /microliter | Standard Deviation 2.8 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average White Blood Cell Count | 2 Year | 7.4 10^3 cells /microliter | Standard Deviation 1.8 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average White Blood Cell Count | Baseline | 7.4 10^3 cells /microliter | Standard Deviation 2.6 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average White Blood Cell Count | Discharge | 10.4 10^3 cells /microliter | Standard Deviation 5.3 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average White Blood Cell Count | 3 Months | 7.1 10^3 cells /microliter | Standard Deviation 2 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's Average White Blood Cell Count | 1 Year | 7.1 10^3 cells /microliter | Standard Deviation 2.3 |
Other Pre-specified
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time frame: 3 Months, 1 Year, and 2 Years Post Implant
Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Same | 200 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Worsened | 17 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Improved | 331 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Year | Improved | 157 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Worsened | 14 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Year | Same | 75 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Same | 161 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Year | Worsened | 8 Participants |
| Edwards Pericardial Bioprosthesis, Models 11000A & 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Improved | 431 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Year | Worsened | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Improved | 66 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Same | 7 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Worsened | 2 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Improved | 66 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Same | 7 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Worsened | 0 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Year | Improved | 26 Participants |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Year | Same | 3 Participants |