Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Conditions
Keywords
Aortic Valve Replacement
Brief summary
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
Detailed description
This is a two-phase, non-randomized, prospective, single arm, multi-center clinical investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per subject.
Interventions
DEVICEAortic Valve Replacement with EDWARDS INTUITY Valve System
Aortic Valve bioprosthesis
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Criteria: Inclusion Criteria: * 18 years or older * Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned replacement as indicated in the preoperative evaluation; * Scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or atrial appendage occlusion/removal. * Signed and dated the informed consent form prior to investigation procedures; * Geographically stable and agrees to attend Follow up assessments at the hospital of surgical services for a maximum of 5 years.
Exclusion criteria
* Pure aortic insufficiency * Requires emergency surgery * Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention * Left ventricular ejection fraction of ≤ 25% * Active endocarditis within 3 months prior to the scheduled aortic valve replacement surgery * Concomitant valve (mitral, tricuspid, or pulmonic) disease requiring repair with an annuloplasty ring or replacement with prosthesis * Prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring. * Myocardial infarction (MI) within 1 month prior to the scheduled aortic valve replacement surgery * Previously implanted with EDWARDS INTUITY Aortic valve; alcohol or drug abuser * Disease limiting life expectancy to less than 12 months * Pregnant or lactating * Currently participating in another drug or device clinical investigation; * Documented blood diatheses * Requires non-cardiac procedures such as carotid procedures or mediastinal tumor removal * Had a stroke or transient ischemic attack (TIA) within 6-months prior to scheduled aortic valve replacement surgery * Study site pre-operative echocardiographic assessment shows evidence of an intracardiac mass, thrombus, or vegetation * Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure * Documented renal insufficiency as determined by Serum creatinine ≥ 200 µmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis * Documented hyperparathyroidism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Early Adverse Events | Events occuring 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. |
| Percent of Late Adverse Events | Events occurring >= 31 days and up through 5 years post-implant | Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. |
| Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Baseline, 3 Months, and 1 Year post-implant | The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. |
| Subject's Average Mean Systolic Gradient Measurements Over Time. | Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. |
| Subject's Average Effective Orifice Area Measurements Over Time. | Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. |
| Subject's Amount of Aortic Valvular Regurgitation Over Time | Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | Aortic valvular regurgitation occurs when the aortic 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. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. |
| Subject's Average White Blood Cell Count Measurement Over Time. | Baseline, 3 Months, 1 Year, and 5 Years post-implant | Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection. |
| Number of Subject's With Device Technical Success | At time of surgery, an average of 3 hours | Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts. |
| Subject's Average Hemoglobin Count Over Time. | Baseline, 3 Months, 1 Year, and 5 Years post-implant | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. |
| Subject's Average Hematocrit Percentage Over Time. | Baseline, 3 Months, 1 Year, and 5 Years post-implant | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood. |
| Subject's Average Platelet Count Over Time. | Baseline, 3 Months, 1 Year, and 5 Years post-implant | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. |
| Subject's Average Reticulocytes Percentage Over Time. | Baseline, 3 Months, 1 Year, and 5 Years post-implant | Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood. |
| Subject's Average Haptoglobin Measurement Over Time. | Baseline, 3 Months, 1 Year, and 5 Years post-implant | Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver. |
| Subject's Average Serum LDH Measurement Over Time. | Baseline, 3 Months, 1 Year, and 5 Years post-implant | The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. |
| Subject's Average Red Blood Cells Count Over Time. | Baseline, 3 Months, 1 Year, and 5 Years post-implant | Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen. |
| Number of Subject's With Procedural Success | Discharge(an average of 13 days) or 10 days post-implant, whichever comes first | Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death. |
Countries
Austria, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve. | 287 |
| Total | 287 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Consented but did not receive device | 8 |
| Overall Study | Death | 51 |
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Subjects declined to return for followup | 9 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | INTUITY Aortic Valve and INTUITY Delivery System | — |
|---|---|---|
| Age, Continuous | 75.3 years STANDARD_DEVIATION 6.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 141 Participants | — |
| Sex: Female, Male Male | 146 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 51 / 287 |
| other Total, other adverse events | 189 / 287 |
| serious Total, serious adverse events | 233 / 287 |
Outcome results
Primary
Percent 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: Events occuring within 30 days of procedure
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | All Cause Mortality | 1.7 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | Trial Valve Related Mortality | 1.0 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | Thromboembolism | 4.5 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | Valve Thrombosis | 0.0 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | Major Bleeding | 7.3 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | All Paravalvular Leak (OPC) | 1.0 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | Hemolysis | 0.7 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | Endocarditis | 0.0 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | Structural Valve Deterioration | 0.0 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | Reoperation | 1.4 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | Explant | 1.4 Percentage of subjects |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Early Adverse Events | Valve Related AE | 3.1 Percentage of subjects |
Primary
Percent of Late Adverse Events
Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Time frame: Events occurring >= 31 days and up through 5 years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | All Cause Mortality | 3.8 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | Trial Valve Related Mortality | 0.4 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | Thromboembolism | 1.9 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | Valve Thrombosis | 0.0 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | Major Bleeding | 2.1 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | All Paravalvular Leak (OPC) | 0.6 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | Hemolysis | 0.2 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | Endocarditis | 0.3 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | Structural Valve Deterioration | 0.5 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | Reoperation | 0.5 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | Explant | 0.5 Percentage of late adverse events |
| INTUITY Aortic Valve and INTUITY Delivery System | Percent of Late Adverse Events | Valve Related AE | 1.0 Percentage of late adverse events |
Other Pre-specified
Number of Subject's With Device Technical Success
Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts.
Time frame: At time of surgery, an average of 3 hours
Population: This outcome is reported for enrolled subjects where data is available. Subjects were considered enrolled after meeting all the enrollment criteria, signing the informed consent, and after the surgeon sized the aortic annulus, and determined that the bioprosthesis could be implanted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Number of Subject's With Device Technical Success | 287 Participants |
Other Pre-specified
Number of Subject's With Procedural Success
Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death.
Time frame: Discharge(an average of 13 days) or 10 days post-implant, whichever comes first
Population: This outcome is reported for enrolled subjects where data is available. Subjects were considered enrolled after meeting all the enrollment criteria, signing the informed consent, and after the surgeon sized the aortic annulus, and determined that the bioprosthesis could be implanted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Number of Subject's With Procedural Success | 277 Participants |
Other Pre-specified
Subject's Amount of Aortic Valvular Regurgitation Over Time
Aortic valvular regurgitation occurs when the aortic 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. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Time frame: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | Discharge | 0 None/+1 Trivial | 244 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | Discharge | +2 Mild | 10 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | Discharge | +3 Moderate | 2 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | Discharge | +4 Severe | 1 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 1 Month | 0 None/+1 Trivial | 10 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 1 Month | +2 Mild | 1 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 1 Month | +3 Moderate | 0 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 1 Month | +4 Severe | 0 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 3 Months | 0 None/+1 Trivial | 235 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 3 Months | +2 Mild | 11 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 3 Months | +3 Moderate | 4 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 3 Months | +4 Severe | 1 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 1 Year | 0 None/+1 Trivial | 231 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 1 Year | +2 Mild | 14 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 1 Year | +3 Moderate | 3 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 1 Year | +4 Severe | 0 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 2 Years | 0 None/+1 Trivial | 86 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 2 Years | +2 Mild | 7 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 2 Years | +3 Moderate | 4 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 2 Years | +4 Severe | 0 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 3 Years | 0 None/+1 Trivial | 177 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 3 Years | +2 Mild | 12 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 3 Years | +3 Moderate | 4 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 3 Years | +4 Severe | 0 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 4 Years | 0 None/+1 Trivial | 125 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 4 Years | +2 Mild | 11 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 4 Years | +3 Moderate | 4 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 4 Years | +4 Severe | 0 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 5 Years | 0 None/+1 Trivial | 161 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 5 Years | +2 Mild | 9 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 5 Years | +3 Moderate | 4 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Amount of Aortic Valvular Regurgitation Over Time | 5 Years | +4 Severe | 0 Participants |
Other Pre-specified
Subject's Average Effective Orifice Area Measurements Over Time.
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Time frame: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Effective Orifice Area Measurements Over Time. | Discharge | 1.7 Centimeters Squared | Standard Deviation 0.2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Effective Orifice Area Measurements Over Time. | 1 Month | 1.6 Centimeters Squared | Standard Deviation 0.2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Effective Orifice Area Measurements Over Time. | 3 Months | 1.7 Centimeters Squared | Standard Deviation 0.2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Effective Orifice Area Measurements Over Time. | 1 Year | 1.7 Centimeters Squared | Standard Deviation 0.2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Effective Orifice Area Measurements Over Time. | 2 Years | 1.7 Centimeters Squared | Standard Deviation 0.2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Effective Orifice Area Measurements Over Time. | 3 Years | 1.7 Centimeters Squared | Standard Deviation 0.2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Effective Orifice Area Measurements Over Time. | 4 Years | 1.7 Centimeters Squared | Standard Deviation 0.3 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Effective Orifice Area Measurements Over Time. | 5 Years | 1.7 Centimeters Squared | Standard Deviation 0.3 |
Other Pre-specified
Subject's Average Haptoglobin Measurement Over Time.
Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Haptoglobin Measurement Over Time. | Baseline | 63.08 g/L | Standard Deviation 69.5 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Haptoglobin Measurement Over Time. | 3 Months | 82.15 g/L | Standard Deviation 81.1 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Haptoglobin Measurement Over Time. | 1 Year | 80.65 g/L | Standard Deviation 80.5 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Haptoglobin Measurement Over Time. | 5 Years | 79.36 g/L | Standard Deviation 81.2 |
Other Pre-specified
Subject's Average Hematocrit Percentage Over Time.
Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Hematocrit Percentage Over Time. | Baseline | 38.29 percentage of red blood cells | Standard Deviation 4.7 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Hematocrit Percentage Over Time. | 3 Months | 38.07 percentage of red blood cells | Standard Deviation 4.1 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Hematocrit Percentage Over Time. | 1 Year | 38.93 percentage of red blood cells | Standard Deviation 4.1 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Hematocrit Percentage Over Time. | 5 Years | 39.58 percentage of red blood cells | Standard Deviation 4.4 |
Other Pre-specified
Subject's Average Hemoglobin Count Over Time.
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Hemoglobin Count Over Time. | Baseline | 12.87 g/dl | Standard Deviation 1.7 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Hemoglobin Count Over Time. | 3 Months | 12.49 g/dl | Standard Deviation 1.4 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Hemoglobin Count Over Time. | 1 Year | 13.00 g/dl | Standard Deviation 1.5 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Hemoglobin Count Over Time. | 5 Years | 13.16 g/dl | Standard Deviation 1.6 |
Other Pre-specified
Subject's Average Mean Systolic 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. Mean gradient values depend on the size and type of valve.
Time frame: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Mean Systolic Gradient Measurements Over Time. | Discharge | 10.6 mmHg | Standard Deviation 4.2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Mean Systolic Gradient Measurements Over Time. | 1 Month | 9.5 mmHg | Standard Deviation 2.8 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Mean Systolic Gradient Measurements Over Time. | 3 Months | 9.0 mmHg | Standard Deviation 3.4 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Mean Systolic Gradient Measurements Over Time. | 1 Year | 9.0 mmHg | Standard Deviation 3.5 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Mean Systolic Gradient Measurements Over Time. | 2 Years | 8.8 mmHg | Standard Deviation 3 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Mean Systolic Gradient Measurements Over Time. | 3 Years | 9.6 mmHg | Standard Deviation 4.3 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Mean Systolic Gradient Measurements Over Time. | 4 Years | 10.0 mmHg | Standard Deviation 4.7 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Mean Systolic Gradient Measurements Over Time. | 5 Years | 9.9 mmHg | Standard Deviation 5.1 |
Other Pre-specified
Subject's Average Platelet Count Over Time.
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Platelet Count Over Time. | Baseline | 220.33 10^3 platelets per microliter | Standard Deviation 66.3 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Platelet Count Over Time. | 3 Months | 223.07 10^3 platelets per microliter | Standard Deviation 59.7 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Platelet Count Over Time. | 1 Year | 213.22 10^3 platelets per microliter | Standard Deviation 60.4 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Platelet Count Over Time. | 5 Years | 206.85 10^3 platelets per microliter | Standard Deviation 63.5 |
Other Pre-specified
Subject's Average Red Blood Cells Count Over Time.
Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Red Blood Cells Count Over Time. | Baseline | 4.30 10^6 cells/microliters | Standard Deviation 0.5 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Red Blood Cells Count Over Time. | 3 Months | 4.40 10^6 cells/microliters | Standard Deviation 0.5 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Red Blood Cells Count Over Time. | 1 Year | 4.36 10^6 cells/microliters | Standard Deviation 0.5 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Red Blood Cells Count Over Time. | 5 Years | 4.35 10^6 cells/microliters | Standard Deviation 0.8 |
Other Pre-specified
Subject's Average Reticulocytes Percentage Over Time.
Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Reticulocytes Percentage Over Time. | Baseline | 2.13 percentage of reticulocytes | Standard Deviation 2.5 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Reticulocytes Percentage Over Time. | 3 Months | 1.59 percentage of reticulocytes | Standard Deviation 1.9 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Reticulocytes Percentage Over Time. | 1 Year | 2.07 percentage of reticulocytes | Standard Deviation 5 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Reticulocytes Percentage Over Time. | 5 Years | 1.82 percentage of reticulocytes | Standard Deviation 2.2 |
Other Pre-specified
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Time frame: Baseline, 3 Months, and 1 Year post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Baseline | 0.79 units on a scale | Standard Deviation 0.2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Follow-Up | 0.87 units on a scale | Standard Deviation 0.18 |
| Baseline and 1 Year Follow-Up | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Baseline | 0.79 units on a scale | Standard Deviation 0.19 |
| Baseline and 1 Year Follow-Up | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | Follow-Up | 0.83 units on a scale | Standard Deviation 0.22 |
Other Pre-specified
Subject's Average Serum LDH Measurement Over Time.
The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Serum LDH Measurement Over Time. | Baseline | 223.91 U/L | Standard Deviation 53 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Serum LDH Measurement Over Time. | 3 Months | 271.37 U/L | Standard Deviation 87.2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Serum LDH Measurement Over Time. | 1 Year | 250.56 U/L | Standard Deviation 76.2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average Serum LDH Measurement Over Time. | 5 Years | 254.46 U/L | Standard Deviation 76.3 |
Other Pre-specified
Subject's Average White Blood Cell Count Measurement Over Time.
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average White Blood Cell Count Measurement Over Time. | Baseline | 6.80 10^3 cells/microliters | Standard Deviation 2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average White Blood Cell Count Measurement Over Time. | 3 Months | 6.97 10^3 cells/microliters | Standard Deviation 1.8 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average White Blood Cell Count Measurement Over Time. | 1 Year | 7.10 10^3 cells/microliters | Standard Deviation 2 |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's Average White Blood Cell Count Measurement Over Time. | 5 Years | 7.31 10^3 cells/microliters | Standard Deviation 2 |
Other Pre-specified
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time frame: 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Population: The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Month | Improved | 121 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Month | Same | 59 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Month | Worsened | 14 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Improved | 189 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Same | 65 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Months | Worsened | 8 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Improved | 191 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Same | 57 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 1 Year | Worsened | 7 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Years | Improved | 180 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Years | Same | 46 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 2 Years | Worsened | 12 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Years | Improved | 157 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Years | Same | 56 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 3 Years | Worsened | 12 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 4 Years | Improved | 137 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 4 Years | Same | 60 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 4 Years | Worsened | 10 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 5 Years | Improved | 125 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 5 Years | Same | 52 Participants |
| INTUITY Aortic Valve and INTUITY Delivery System | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | 5 Years | Worsened | 16 Participants |