Congenital Pulmonary Valve Abnormality, Pulmonary Valve Degeneration, Pulmonary Valve Insufficiency
Conditions
Brief summary
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Detailed description
This is a prospective, Non-Randomized, Single Arm, Multicenter study. Up to one hundred (100) pulmonary valve replacement (PVR) subjects at up to ten (10) clinical sites will be enrolled. Clinical data will be collected from at least 3 centers with data available on patients who have completed the 1 year follow-up visit. Subjects will be followed for and assessed after implant for up to 5 years.
Interventions
DEVICEEdwards Pericardial Aortic Bioprosthesis Model 11000A
Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve 2. Is greater than or equal to 5 years of age 3. Subject and/or subject's legal representative has provided written informed consent as approved and required by the respective institutional review board and agrees to its provisions. NOTE: Written consent must be obtained prior to any research related test being performed.
Exclusion criteria
A subject meeting any of the following criteria shall be excluded: 1. Valve-in-conduit procedure 2. Requires emergency surgery 3. Has acute myocardial infarction (MI) within 30 days prior to screening date 4. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to screening date 5. Has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to screening date 6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to screening date 7. Has renal insufficiency as determined by creatinine (S-Cr) level \ 2.5 mg/dL within 60 days prior to screening visit or end-stage renal disease 8. Has documented leukopenia (WBC \< 3.5x 103/I-lL), acute anemia (Hgb \<10.0 g/dL or 6 mmol/L), or thrombocytopenia (platelet count \< 50xl03/I-lL) accompanied by history of bleeding diathesis or coagulopathy within 60 days prior to screening date 9. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism 10. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation 11. RVOT aneurysm unless treated during pulmonary valve replacement surgery 12. Has prior organ transplant or is currently an organ transplant candidate 13. Was previously implanted with INSPIRIS RESILIA Pulmonary valve 14. Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve, mechanical valve, or annuloplasty ring 15. Need for concomitant replacement of the aortic, mitral or tricuspid valves 16. Has presence of non-cardiac disease limiting life expectancy to less than 12 months 17. Is Currently or has recently participated (within 6 weeks) in another investigational drug or device trial 18. Positive urine or serum pregnancy test in female subjects of child-bearing potential and/or nursing mothers, or planning to become pregnant within 1 year of study valve implant 19. Has left ventricular ejection fraction ≤20% as validated by diagnostic procedure prior to screening date 20. Currently incarcerated or unable to give voluntary informed consent 21. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to screening date 22. Patients with hypersensitivity to metal alloys that contain cobalt, chromium, nickel, molybdenum, manganese, carbon, beryllium and iron 23. Patients with hypersensitivity to latex Intra-Op Exclusion Criterion: 24. Significant injury to the heart upon entry defined as emergent cardiopulmonary bypass requiring femoral cannulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant. | 1-year post-implant | Subject's freedom from device or procedure related death and/or reoperation at 1-year post-implant. Time to events were estimated by Kaplan-Meier method. A higher number means a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Events occurring ≥ 31 days and up through 5 years post implant. | Late patient years are calculated from 31 days post-implant to the date of the last follow-up visit (or contact) or adverse event. Late patient year calculation: \[(Number of late events/sum of late patient years) x 100\] |
| Subject's Average Mean Gradient Measurements Over Time. | Baseline, 30 days, 3 months, and annually thereafter for up to 5 years | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve. |
| Subject's Average Peak Gradient Measurements Over Time. | Baseline, 30 days, 3 months, and annually thereafter for up to 5 years | 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. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve. |
| Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge, 30 days, 3 months, and annually thereafter for up to 5 years | 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 0 to 4, where 0 represents no regurgitation/leak (a better outcome) and 4 represents severe regurgitation/leak (a worse outcome). |
| Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge, 30 days, 3 months, and annually thereafter for up to 5 years | 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 (a better outcome) and 4 represents severe regurgitation (a worse outcome). |
| Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | Baseline, 30 days, 3 months, and annually thereafter for up to 5 years | Tricuspid regurgitation (TR) gradient (peak systolic) is defined as the maximum value measured of blood flowing back through the tricuspid valve during systole as measured in millimeters of mercury. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve. |
| Subject's Average Peak Velocity Measurement Over Time | Baseline, 30 days, 3 months, and annually thereafter for up to 5 years | Peak velocity is defined as the maximum speed in meters per second that the blood is flowing through the pulmonic heart valve in a given direction. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve. |
| Subject's Average Doppler Velocity Index (DVI) | Baseline, 30 days, 3 months, and annually thereafter for up to 5 years | The Doppler Velocity Index (DVI) is a calculation of the ratio of the sub valvular velocity obtained by pulse wave Doppler and the maximum velocity obtained by continuous wave Doppler across the prosthetic valve, i.e. Time velocity interval (TVI) of the pulmonic valve / TVI of the RVOT. There are no normal ranges issued by the American Society of Echocardiography's Guidelines and Standards Committee for the pulmonary valve, however the expectation is that DVI should remain relatively steady over time but will generally decrease as the degree of stenosis (narrowing or constriction of the valve opening) worsens. |
| Subject's Average Transvalvular Velocity Time Interval (VTI) | Baseline, 30 days, 3 months, and annually thereafter for up to 5 years | Transvalvular regurgitation velocity time interval (VTI) is defined as the measurement in centimeters of the blood flowing backwards through the tricuspid valve, averaged over time. There are no defined normal ranges for VTI. The VTI value is dependent on the function of the right ventricle of the heart (chamber within the heart that is responsible for pumping oxygen-depleted blood to the lungs) and the expectation is the value should be relatively steady over time. |
| Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | Baseline, 30 days, 3 months, and annually thereafter for up to 5 years | The New York Heart Association (NYHA)/Modified Ross 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, shortness of breath. Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath. Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or shortness of breath. 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. Changes in NYHA/Modified Ross HF classification from the preoperative baseline to the respective completed follow-up visits are shown as the number of subjects in each class who improved, worsened, or stayed the same. |
| Percentage of Early Adverse Events | Percentage of events occurring within 30 days of procedure | Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject's Average Hemoglobin Count | Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years | This is the laboratory analysis of Hemoglobin count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong. |
| Subject's Average Hematocrit Percentage | Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years | This is laboratory analysis of Hematocrit percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong. |
| Subject's Average Platelet Count | Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years | This is laboratory analysis of Platelet count on blood drawn from subjects. The purpose of platelets is to create hemostasis, which is the prevention of hemorrhaging (bleeding) and the process of keeping blood inside the vessel walls. A normal platelet range is 150 to 450 10\^3 cells/microliter. In general, results either lower or higher than the normal range can indicate something is wrong. |
| Subject's Average Serum LDH | Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years | The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. Normal levels of LDH in the blood can vary depending on the lab, but usually range between 140 units per liter (U/L) to 280 U/L for adults and tend to be higher for children and teens. |
| Subject's Average Plasma Free Hemoglobin | Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years | Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong. |
| Subject's Average International Normalized Ratio (INR) | Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years | 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 liquid portion (plasma) of the blood to clot. The normal range of INR depends on the patient. If they are not on an anticoagulant therapy, then the normal range is 0.9 - 1.1 and if they are on anticoagulant therapy then the normal range is 2 - 3. |
| Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under) | Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years | Urobilinogen is a substance that is produced when bilirubin, a waste product produced by the breakdown of red blood cells, is processed in the liver and released into the intestine. The normal range of urobilinogen is less than 1 mg/dL. It is common to have values within the 0 to 8 mg/dL range. In general, results either lower or higher than the normal range can indicate something is wrong. |
| Subject's Average Red Blood Cell Count | Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years | The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10\^6 cells/microliters and for men is 4.7 to 6.1 10\^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong. |
| Subject's Average White Blood Cell Count | Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years | Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10.0 10\^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Reintervention | 3 |
Baseline characteristics
| Characteristic | Edwards Pericardial Aortic Bioprosthesis Model 11000A | — |
|---|---|---|
| Age, Continuous | 18.7 years STANDARD_DEVIATION 10 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 22 / 26 |
| serious Total, serious adverse events | 10 / 26 |
Outcome results
Primary
Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant.
Subject's freedom from device or procedure related death and/or reoperation at 1-year post-implant. Time to events were estimated by Kaplan-Meier method. A higher number means a better outcome.
Time frame: 1-year post-implant
Population: The outcome is reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant. | 100.0 percentage of subjects |
Secondary
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size
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 0 to 4, where 0 represents no regurgitation/leak (a better outcome) and 4 represents severe regurgitation/leak (a worse outcome).
Time frame: Discharge, 30 days, 3 months, and annually thereafter for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | None (0) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | None (0) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | None (0) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | None (0) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | None (0) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | None (0) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | None (0) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | None (0) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | None (0) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | None (0) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0) | 8 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Trival/Trace (+1) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | None (0) | 9 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Trival/Trace (+1) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0) | 11 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | None (0) | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Trival/Trace (+1) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | None (0) | 11 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | None (0) | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | None (0) | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | None (0) | 8 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | None (0) | 9 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0) | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | None (0) | 5 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0) | 7 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | None (0) | 8 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | None (0) | 9 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Trival/Trace (+1) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | None (0) | 7 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | None (0) | 8 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
Secondary
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size
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 (a better outcome) and 4 represents severe regurgitation (a worse outcome).
Time frame: Discharge, 30 days, 3 months, and annually thereafter for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Mild (+2) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Moderate (+3) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Trival/Trace (+1) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Severe (+4) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Mild (+2) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Severe (+4) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Mild (+2) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Trival/Trace (+1) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Mild (+2) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Mild (+2) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Trival/Trace (+1) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Moderate (+3) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Severe (+4) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Severe (+4) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Trival/Trace (+1) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Trival/Trace (+1) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Severe (+4) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Trival/Trace (+1) | 11 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Trival/Trace (+1) | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Trival/Trace (+1) | 7 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | None (0) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Trival/Trace (+1) | 7 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Mild (+2) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Moderate (+3) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Trival/Trace (+1) | 6 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Mild (+2) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Moderate (+3) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Trival/Trace (+1) | 4 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Mild (+2) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Moderate (+3) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Trival/Trace (+1) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Mild (+2) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Moderate (+3) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Severe (+4) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Trival/Trace (+1) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Mild (+2) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Moderate (+3) | 4 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Severe (+4) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Moderate (+3) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Mild (+2) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Trival/Trace (+1) | 5 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Severe (+4) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Mild (+2) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Trival/Trace (+1) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Mild (+2) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Mild (+2) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | Trival/Trace (+1) | 6 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Mild (+2) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Moderate (+3) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 months | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Severe (+4) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 4 years | Severe (+4) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Severe (+4) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Moderate (+3) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Mild (+2) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | Trival/Trace (+1) | 6 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Severe (+4) | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Trival/Trace (+1) | 9 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Mild (+2) | 5 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 5 years | Trival/Trace (+1) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Trival/Trace (+1) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | Trival/Trace (+1) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 2 years | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 30 days | None (0) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 3 years | Mild (+2) | 3 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Severe (+4) | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | 1 year | Moderate (+3) | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size | Discharge | Severe (+4) | 0 Participants |
Secondary
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class
The New York Heart Association (NYHA)/Modified Ross 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, shortness of breath. Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath. Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or shortness of breath. 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. Changes in NYHA/Modified Ross HF classification from the preoperative baseline to the respective completed follow-up visits are shown as the number of subjects in each class who improved, worsened, or stayed the same.
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. NYHA was performed for subjects ≥13 years and the Modified Ross was performed for subjects ≤12 years. The following subjects converted to NYHA from Ross at the follow-up visit(s) due to meeting the age criteria: #6 at 5 Year, #7 at 5 Year, #13 at 4 Year and 5 Year, #22 at 3 Year, 4 Year and 5 Year.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Same | 14 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Same | 13 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Worsened | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Same | 15 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Worsened | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Worsened | 1 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Same | 14 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Same | 9 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Same | 16 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Same | 14 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Improved | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Improved | 5 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Improved | 9 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Improved | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Improved | 8 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Improved | 10 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Same | 2 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Improved | 9 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 1 year | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 4 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 months | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 5 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Improved | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 30 days | Same | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 3 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Worsened | 0 Participants |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class | 2 years | Same | 0 Participants |
Secondary
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort.
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visit (or contact) or adverse event. Late patient year calculation: \[(Number of late events/sum of late patient years) x 100\]
Time frame: Events occurring ≥ 31 days and up through 5 years post implant.
Population: The outcome is reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | All cause death | 0.0 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Valve related death | 0.0 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | All Paravalvular leak (PVL) | 0.0 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | All Transvalvular Leak (TVL) | 13.7 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Major Transvalvular Leak | 2.3 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Minor Transvalvular | 11.4 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Endocarditis | 0.0 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Reintervention | 2.3 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Explant | 0.0 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Thromboembolism | 0.0 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Structural Valve Deterioration | 2.3 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Non-Structural Valve Deterioration other than PVL | 0.0 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Valve Thrombosis - Pulmonary | 0.0 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | All Bleeding | 0.8 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Major Bleeding | 0.0 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Minor Bleeding | 0.8 Percentage of events/late patient years |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. | Hemolysis | 0.0 Percentage of events/late patient years |
Secondary
Percentage of Early Adverse Events
Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Time frame: Percentage of events occurring within 30 days of procedure
Population: The outcome is reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Explant | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Endocarditis | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Reintervention | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Thromboembolism | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Structural Valve Deterioration | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | All Cause Death | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Valve Related Death | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | All Paravalvular Leak (PVL) | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | All Transvalvular Leak (TVL) | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Major Transvalvular Leak | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Minor Transvalvular Leak | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Non-Structural Valve Deterioration Other than Paravalvular Leak | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Valve Thrombosis - Pulmonary | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | All Bleeding | 3.8 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Major Bleeding | 3.8 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Minor Bleeding | 0.0 percentage of subjects |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Percentage of Early Adverse Events | Hemolysis | 0.0 percentage of subjects |
Secondary
Subject's Average Doppler Velocity Index (DVI)
The Doppler Velocity Index (DVI) is a calculation of the ratio of the sub valvular velocity obtained by pulse wave Doppler and the maximum velocity obtained by continuous wave Doppler across the prosthetic valve, i.e. Time velocity interval (TVI) of the pulmonic valve / TVI of the RVOT. There are no normal ranges issued by the American Society of Echocardiography's Guidelines and Standards Committee for the pulmonary valve, however the expectation is that DVI should remain relatively steady over time but will generally decrease as the degree of stenosis (narrowing or constriction of the valve opening) worsens.
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Doppler Velocity Index (DVI) | 3 months | 0.7 Ratio | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Doppler Velocity Index (DVI) | 5 Years | 0.2 Ratio | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Doppler Velocity Index (DVI) | 3 Years | 0.3 Ratio | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Doppler Velocity Index (DVI) | 2 Years | 0.5 Ratio | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Doppler Velocity Index (DVI) | 1 Year | 0.5 Ratio | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Doppler Velocity Index (DVI) | Baseline | 0.7 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Doppler Velocity Index (DVI) | 3 months | 0.5 Ratio | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Doppler Velocity Index (DVI) | 2 Years | 0.4 Ratio | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Doppler Velocity Index (DVI) | 3 Years | 0.4 Ratio | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Doppler Velocity Index (DVI) | 5 Years | 0.4 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Doppler Velocity Index (DVI) | 3 Years | 0.5 Ratio | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Doppler Velocity Index (DVI) | 2 Years | 0.5 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Doppler Velocity Index (DVI) | 4 Years | 0.4 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Doppler Velocity Index (DVI) | 1 Year | 0.4 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Doppler Velocity Index (DVI) | Baseline | 0.6 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Doppler Velocity Index (DVI) | 3 months | 0.5 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Doppler Velocity Index (DVI) | 30 days | 0.5 Ratio | Standard Deviation 0 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Doppler Velocity Index (DVI) | 3 months | 0.4 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Doppler Velocity Index (DVI) | 1 Year | 0.5 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Doppler Velocity Index (DVI) | 2 Years | 0.5 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Doppler Velocity Index (DVI) | Baseline | 0.6 Ratio | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Doppler Velocity Index (DVI) | 5 Years | 0.6 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Doppler Velocity Index (DVI) | 3 Years | 0.4 Ratio | Standard Deviation 0.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Doppler Velocity Index (DVI) | 4 Years | 0.5 Ratio | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Doppler Velocity Index (DVI) | 30 days | 0.5 Ratio | Standard Deviation 0.1 |
Secondary
Subject's Average Mean Gradient Measurements Over Time.
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Mean Gradient Measurements Over Time. | 2 Years | 14.4 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Mean Gradient Measurements Over Time. | 3 Years | 35.1 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Mean Gradient Measurements Over Time. | 3 months | 9.5 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Mean Gradient Measurements Over Time. | 1 Year | 15.0 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Mean Gradient Measurements Over Time. | 5 Years | 44.6 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Mean Gradient Measurements Over Time. | 3 months | 12.9 mmHg | Standard Deviation 3.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Mean Gradient Measurements Over Time. | 2 Years | 14.3 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Mean Gradient Measurements Over Time. | 3 Years | 24.9 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Mean Gradient Measurements Over Time. | Baseline | 8.0 mmHg | Standard Deviation 1.7 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Mean Gradient Measurements Over Time. | 3 months | 9.5 mmHg | Standard Deviation 3.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Mean Gradient Measurements Over Time. | Baseline | 9.0 mmHg | Standard Deviation 8.6 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Mean Gradient Measurements Over Time. | 30 days | 7.7 mmHg | Standard Deviation 2.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Mean Gradient Measurements Over Time. | 1 Year | 10.9 mmHg | Standard Deviation 4.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Mean Gradient Measurements Over Time. | 2 Years | 10.8 mmHg | Standard Deviation 3.8 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Mean Gradient Measurements Over Time. | 3 Years | 10.8 mmHg | Standard Deviation 3.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Mean Gradient Measurements Over Time. | 4 Years | 11.4 mmHg | Standard Deviation 3.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Mean Gradient Measurements Over Time. | 5 Years | 11.8 mmHg | Standard Deviation 2.6 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Mean Gradient Measurements Over Time. | Baseline | 8.4 mmHg | Standard Deviation 3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Mean Gradient Measurements Over Time. | 3 months | 8.8 mmHg | Standard Deviation 2.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Mean Gradient Measurements Over Time. | 3 Years | 11.7 mmHg | Standard Deviation 5.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Mean Gradient Measurements Over Time. | 5 Years | 10.9 mmHg | Standard Deviation 4.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Mean Gradient Measurements Over Time. | 1 Year | 10.3 mmHg | Standard Deviation 4.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Mean Gradient Measurements Over Time. | 4 Years | 11.3 mmHg | Standard Deviation 4.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Mean Gradient Measurements Over Time. | 2 Years | 10.7 mmHg | Standard Deviation 3.7 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Mean Gradient Measurements Over Time. | 30 days | 7.8 mmHg | Standard Deviation 2.8 |
Secondary
Subject's Average Peak Gradient Measurements Over Time.
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. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Peak Gradient Measurements Over Time. | 5 Years | 77.8 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Peak Gradient Measurements Over Time. | 1 Year | 26.8 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Peak Gradient Measurements Over Time. | 3 months | 17.0 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Peak Gradient Measurements Over Time. | 2 Years | 23.4 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Peak Gradient Measurements Over Time. | 3 Years | 62.4 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Peak Gradient Measurements Over Time. | 3 Years | 42.0 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Peak Gradient Measurements Over Time. | 3 months | 22.5 mmHg | Standard Deviation 5.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Peak Gradient Measurements Over Time. | Baseline | 15.6 mmHg | Standard Deviation 2.9 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Peak Gradient Measurements Over Time. | 2 Years | 23.8 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Gradient Measurements Over Time. | Baseline | 16.1 mmHg | Standard Deviation 14.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Gradient Measurements Over Time. | 5 Years | 20.9 mmHg | Standard Deviation 5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Gradient Measurements Over Time. | 1 Year | 19.1 mmHg | Standard Deviation 7.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Gradient Measurements Over Time. | 30 days | 13.7 mmHg | Standard Deviation 4.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Gradient Measurements Over Time. | 4 Years | 19.9 mmHg | Standard Deviation 5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Gradient Measurements Over Time. | 3 Years | 19.2 mmHg | Standard Deviation 6.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Gradient Measurements Over Time. | 2 Years | 19.4 mmHg | Standard Deviation 6.7 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Gradient Measurements Over Time. | 3 months | 16.7 mmHg | Standard Deviation 6.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Gradient Measurements Over Time. | 5 Years | 19.8 mmHg | Standard Deviation 7.9 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Gradient Measurements Over Time. | Baseline | 16.4 mmHg | Standard Deviation 5.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Gradient Measurements Over Time. | 30 days | 13.6 mmHg | Standard Deviation 4.8 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Gradient Measurements Over Time. | 3 months | 15.5 mmHg | Standard Deviation 3.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Gradient Measurements Over Time. | 1 Year | 18.3 mmHg | Standard Deviation 7.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Gradient Measurements Over Time. | 2 Years | 19.1 mmHg | Standard Deviation 6.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Gradient Measurements Over Time. | 3 Years | 20.6 mmHg | Standard Deviation 8.9 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Gradient Measurements Over Time. | 4 Years | 19.7 mmHg | Standard Deviation 7.3 |
Secondary
Subject's Average Peak Velocity Measurement Over Time
Peak velocity is defined as the maximum speed in meters per second that the blood is flowing through the pulmonic heart valve in a given direction. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Peak Velocity Measurement Over Time | 1 Year | 2.6 m/s | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Peak Velocity Measurement Over Time | 2 Years | 2.4 m/s | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Peak Velocity Measurement Over Time | 3 Months | 2.1 m/s | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Peak Velocity Measurement Over Time | 3 Years | 4.0 m/s | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Peak Velocity Measurement Over Time | 5 Years | 4.4 m/s | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Peak Velocity Measurement Over Time | 3 Years | 3.2 m/s | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Peak Velocity Measurement Over Time | 3 Months | 2.4 m/s | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Peak Velocity Measurement Over Time | 2 Years | 2.4 m/s | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Peak Velocity Measurement Over Time | Baseline | 2.0 m/s | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Velocity Measurement Over Time | Baseline | 1.8 m/s | Standard Deviation 0.8 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Velocity Measurement Over Time | 30 days | 1.8 m/s | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Velocity Measurement Over Time | 3 Months | 2.0 m/s | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Velocity Measurement Over Time | 1 Year | 2.2 m/s | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Velocity Measurement Over Time | 2 Years | 2.2 m/s | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Velocity Measurement Over Time | 3 Years | 2.1 m/s | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Velocity Measurement Over Time | 4 Years | 2.1 m/s | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Peak Velocity Measurement Over Time | 5 Years | 2.3 m/s | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Velocity Measurement Over Time | 3 Years | 2.2 m/s | Standard Deviation 0.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Velocity Measurement Over Time | 30 days | 1.8 m/s | Standard Deviation 0.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Velocity Measurement Over Time | 4 Years | 2.2 m/s | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Velocity Measurement Over Time | 3 Months | 2.0 m/s | Standard Deviation 0.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Velocity Measurement Over Time | Baseline | 2.0 m/s | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Velocity Measurement Over Time | 2 Years | 2.2 m/s | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Velocity Measurement Over Time | 1 Year | 2.1 m/s | Standard Deviation 0.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Peak Velocity Measurement Over Time | 5 Years | 2.1 m/s | Standard Deviation 0.5 |
Secondary
Subject's Average Transvalvular Velocity Time Interval (VTI)
Transvalvular regurgitation velocity time interval (VTI) is defined as the measurement in centimeters of the blood flowing backwards through the tricuspid valve, averaged over time. There are no defined normal ranges for VTI. The VTI value is dependent on the function of the right ventricle of the heart (chamber within the heart that is responsible for pumping oxygen-depleted blood to the lungs) and the expectation is the value should be relatively steady over time.
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Transvalvular Velocity Time Interval (VTI) | 1 Year | 61.1 cm | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 3 Months | 73.9 cm | Standard Deviation 11.9 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 5 Years | 98.7 cm | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | Baseline | 70.2 cm | Standard Deviation 7.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 1 Year | 76.9 cm | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 2 Years | 77.3 cm | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 3 Years | 87.9 cm | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | Baseline | 82.9 cm | Standard Deviation 35.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 3 Years | 73.1 cm | Standard Deviation 18.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 2 Years | 81.3 cm | Standard Deviation 17.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 3 Months | 86.9 cm | Standard Deviation 16.8 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 4 Years | 96.0 cm | Standard Deviation 16.9 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 30 days | 77.8 cm | Standard Deviation 19.7 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 1 Year | 82.4 cm | Standard Deviation 18.8 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 5 Years | 79.3 cm | Standard Deviation 20.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 5 Years | 74.1 cm | Standard Deviation 18.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | Baseline | 76.5 cm | Standard Deviation 12 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 30 days | 69.0 cm | Standard Deviation 17.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 3 Months | 75.9 cm | Standard Deviation 15.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 1 Year | 73.9 cm | Standard Deviation 13.8 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 2 Years | 64.1 cm | Standard Deviation 15.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 3 Years | 70.3 cm | Standard Deviation 16.8 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Transvalvular Velocity Time Interval (VTI) | 4 Years | 79.1 cm | Standard Deviation 16.9 |
Secondary
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time.
Tricuspid regurgitation (TR) gradient (peak systolic) is defined as the maximum value measured of blood flowing back through the tricuspid valve during systole as measured in millimeters of mercury. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 1 Year | 23.6 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | Baseline | 21.5 mmHg | Standard Deviation 0.6 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 3 months | 31.6 mmHg | Standard Deviation 7.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 1 Year | 30.2 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 2 Years | 27.7 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 3 Years | 37.2 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 4 Years | 28.0 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 5 Years | 42.8 mmHg | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | Baseline | 36.2 mmHg | Standard Deviation 30.6 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 4 Years | 35.5 mmHg | Standard Deviation 8.9 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 1 Year | 27.7 mmHg | Standard Deviation 7.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 2 Years | 30.9 mmHg | Standard Deviation 9.7 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 3 Years | 29.2 mmHg | Standard Deviation 12 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 30 days | 30.8 mmHg | Standard Deviation 9.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 5 Years | 30.3 mmHg | Standard Deviation 8.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 3 months | 32.9 mmHg | Standard Deviation 9.4 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 30 days | 25.2 mmHg | Standard Deviation 7.2 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 3 Years | 29.2 mmHg | Standard Deviation 7.7 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | Baseline | 28.8 mmHg | Standard Deviation 6.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 1 Year | 27.7 mmHg | Standard Deviation 3.8 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 4 Years | 29.9 mmHg | Standard Deviation 10.1 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 3 months | 28.8 mmHg | Standard Deviation 6.9 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 2 Years | 24.0 mmHg | Standard Deviation 8 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm | Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. | 5 Years | 29.4 mmHg | Standard Deviation 8.3 |
Other Pre-specified
Subject's Average Hematocrit Percentage
This is laboratory analysis of Hematocrit percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.
Time frame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hematocrit Percentage | Baseline | 41.17 Percentage of red blood cells | Standard Deviation 3.51 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hematocrit Percentage | Discharge | 32.35 Percentage of red blood cells | Standard Deviation 2.97 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hematocrit Percentage | 30 days | 37.22 Percentage of red blood cells | Standard Deviation 3.3 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hematocrit Percentage | 3 months | 40.47 Percentage of red blood cells | Standard Deviation 2.99 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hematocrit Percentage | 1 year | 40.86 Percentage of red blood cells | Standard Deviation 3.53 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hematocrit Percentage | 2 years | 41.88 Percentage of red blood cells | Standard Deviation 3.61 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hematocrit Percentage | 3 years | 39.81 Percentage of red blood cells | Standard Deviation 4.05 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hematocrit Percentage | 4 years | 41.61 Percentage of red blood cells | Standard Deviation 2.92 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hematocrit Percentage | 5 years | 40.30 Percentage of red blood cells | Standard Deviation 3.9 |
Other Pre-specified
Subject's Average Hemoglobin Count
This is the laboratory analysis of Hemoglobin count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.
Time frame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hemoglobin Count | Baseline | 13.61 g/dL | Standard Deviation 1.47 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hemoglobin Count | Discharge | 10.80 g/dL | Standard Deviation 1.07 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hemoglobin Count | 30 days | 12.18 g/dL | Standard Deviation 1.17 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hemoglobin Count | 3 months | 13.34 g/dL | Standard Deviation 1.04 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hemoglobin Count | 1 year | 13.62 g/dL | Standard Deviation 1.33 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hemoglobin Count | 2 years | 14.13 g/dL | Standard Deviation 1.41 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hemoglobin Count | 3 years | 13.06 g/dL | Standard Deviation 1.59 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hemoglobin Count | 4 years | 13.84 g/dL | Standard Deviation 0.89 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Hemoglobin Count | 5 years | 13.11 g/dL | Standard Deviation 1.16 |
Other Pre-specified
Subject's Average International Normalized Ratio (INR)
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 liquid portion (plasma) of the blood to clot. The normal range of INR depends on the patient. If they are not on an anticoagulant therapy, then the normal range is 0.9 - 1.1 and if they are on anticoagulant therapy then the normal range is 2 - 3.
Time frame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
Population: This outcome is reported for subjects who received the trial valve who were on anticoagulant therapy during the trial. Note that only three of the 26 total participants were on anticoagulant therapy and that the number of participants analyzed is different from that in the participant flow as there was also some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average International Normalized Ratio (INR) | 30 days | 1.99 Ratio of blood clotting | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average International Normalized Ratio (INR) | Baseline | 1.05 Ratio of blood clotting | Standard Deviation 0.02 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average International Normalized Ratio (INR) | Discharge | 1.23 Ratio of blood clotting | Standard Deviation 0.27 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average International Normalized Ratio (INR) | 1 year | 2.45 Ratio of blood clotting | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average International Normalized Ratio (INR) | 3 years | 1.02 Ratio of blood clotting | — |
Other Pre-specified
Subject's Average Plasma Free Hemoglobin
Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.
Time frame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. The protocol allowed subjects to have the option of having a serum LDH test or plasma free hemoglobin test or a haptoglobin test at each timeframe. Not all three tests were required for the subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Plasma Free Hemoglobin | Baseline | 45.00 mg/dl | Standard Deviation 33.54 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Plasma Free Hemoglobin | Discharge | 30.00 mg/dl | — |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Plasma Free Hemoglobin | 1 year | 5.80 mg/dl | — |
Other Pre-specified
Subject's Average Platelet Count
This is laboratory analysis of Platelet count on blood drawn from subjects. The purpose of platelets is to create hemostasis, which is the prevention of hemorrhaging (bleeding) and the process of keeping blood inside the vessel walls. A normal platelet range is 150 to 450 10\^3 cells/microliter. In general, results either lower or higher than the normal range can indicate something is wrong.
Time frame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Platelet Count | Baseline | 223.04 10^3 cells/microliter | Standard Deviation 55.45 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Platelet Count | Discharge | 183.42 10^3 cells/microliter | Standard Deviation 54 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Platelet Count | 30 days | 304.84 10^3 cells/microliter | Standard Deviation 108.21 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Platelet Count | 3 months | 249.06 10^3 cells/microliter | Standard Deviation 70.77 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Platelet Count | 1 year | 240.17 10^3 cells/microliter | Standard Deviation 67.06 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Platelet Count | 2 years | 242.77 10^3 cells/microliter | Standard Deviation 64.46 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Platelet Count | 3 years | 252.17 10^3 cells/microliter | Standard Deviation 69.17 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Platelet Count | 4 years | 229.75 10^3 cells/microliter | Standard Deviation 89.74 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Platelet Count | 5 years | 232.25 10^3 cells/microliter | Standard Deviation 48.12 |
Other Pre-specified
Subject's Average Red Blood Cell Count
The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10\^6 cells/microliters and for men is 4.7 to 6.1 10\^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong.
Time frame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Red Blood Cell Count | Baseline | 4.70 10^6 cells/microliter | Standard Deviation 0.33 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Red Blood Cell Count | Discharge | 3.69 10^6 cells/microliter | Standard Deviation 0.37 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Red Blood Cell Count | 30 days | 4.25 10^6 cells/microliter | Standard Deviation 0.31 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Red Blood Cell Count | 3 months | 4.69 10^6 cells/microliter | Standard Deviation 0.26 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Red Blood Cell Count | 1 year | 4.62 10^6 cells/microliter | Standard Deviation 0.38 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Red Blood Cell Count | 2 years | 4.75 10^6 cells/microliter | Standard Deviation 0.41 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Red Blood Cell Count | 3 years | 4.47 10^6 cells/microliter | Standard Deviation 0.26 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Red Blood Cell Count | 4 years | 4.49 10^6 cells/microliter | Standard Deviation 0.31 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Red Blood Cell Count | 5 years | 4.46 10^6 cells/microliter | Standard Deviation 0.43 |
Other Pre-specified
Subject's Average Serum LDH
The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. Normal levels of LDH in the blood can vary depending on the lab, but usually range between 140 units per liter (U/L) to 280 U/L for adults and tend to be higher for children and teens.
Time frame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. The protocol allowed subjects to have the option of having a serum LDH test or plasma free hemoglobin test or a haptoglobin test at each timeframe. Not all three tests were required for the subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Serum LDH | Baseline | 153.69 U/L | Standard Deviation 32.84 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Serum LDH | Discharge | 282.82 U/L | Standard Deviation 61.92 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Serum LDH | 30 days | 207.77 U/L | Standard Deviation 34.15 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Serum LDH | 3 months | 224.59 U/L | Standard Deviation 49.81 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Serum LDH | 1 year | 201.00 U/L | Standard Deviation 45.37 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Serum LDH | 2 years | 199.15 U/L | Standard Deviation 40.5 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Serum LDH | 3 years | 209.50 U/L | Standard Deviation 44.07 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Serum LDH | 4 years | 203.75 U/L | Standard Deviation 37.16 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average Serum LDH | 5 years | 192.60 U/L | Standard Deviation 22.81 |
Other Pre-specified
Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under)
Urobilinogen is a substance that is produced when bilirubin, a waste product produced by the breakdown of red blood cells, is processed in the liver and released into the intestine. The normal range of urobilinogen is less than 1 mg/dL. It is common to have values within the 0 to 8 mg/dL range. In general, results either lower or higher than the normal range can indicate something is wrong.
Time frame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
Population: This outcome is reported for subjects who received the trial valve and required the urine urobilinogen clinical test. There were no subjects in the trial who required this clinical test.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under) | 3 months | — |
| Unknown | Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under) | 1 year | — |
| Unknown | Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under) | 30 days | — |
| Unknown | Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under) | Baseline | — |
| Unknown | Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under) | Discharge | — |
| Unknown | Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under) | 2 years | — |
| Unknown | Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under) | 3 years | — |
| Unknown | Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under) | 4 years | — |
| Unknown | Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under) | 5 years | — |
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. The normal reference range for WBC count is 4.5 to 10.0 10\^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.
Time frame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average White Blood Cell Count | 3 months | 6.15 10^3 cells/microliters | Standard Deviation 1.38 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average White Blood Cell Count | 1 year | 5.57 10^3 cells/microliters | Standard Deviation 1.24 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average White Blood Cell Count | 2 years | 6.13 10^3 cells/microliters | Standard Deviation 1.35 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average White Blood Cell Count | 3 years | 5.70 10^3 cells/microliters | Standard Deviation 1.74 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average White Blood Cell Count | 4 years | 6.02 10^3 cells/microliters | Standard Deviation 1.43 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average White Blood Cell Count | Baseline | 5.94 10^3 cells/microliters | Standard Deviation 1.41 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average White Blood Cell Count | Discharge | 7.40 10^3 cells/microliters | Standard Deviation 2.12 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average White Blood Cell Count | 30 days | 7.60 10^3 cells/microliters | Standard Deviation 2.47 |
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Subject's Average White Blood Cell Count | 5 years | 6.55 10^3 cells/microliters | Standard Deviation 1.02 |