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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130009 S034/ PAS001 |
| Date Original Protocol Accepted |
10/09/2015
|
| Date Current Protocol Accepted |
11/04/2019
|
| Study Name |
Continued f/u of the premarket cohort
|
| Device Name |
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of premarket cohorts. The objective of this study is to characterize the cumulative clinical outcomes of all subjects at discharge or 7 days, whichever comes first, 30 days, 1 year, and annually thereafter through 5 years post procedure.
|
| Study Population |
The study will consist of all living subjects who were enrolled in Nested Registry 3 under the IDE, including those enrolled under the continued access protocol.
|
| Sample Size |
All living subjects
|
| Key Study Endpoints |
The safety and effectiveness endpoints include all-cause mortality, all stroke, moderate or severe obstruction (defined as Doppler Velocity Index [DVI] < 0.25), or moderate or severe paravalvular leak (through 1 year only); all-cause mortality; all stroke or transient ischemic attack (TIA); all-cause mortality or major stroke; all stroke, major vascular complication, or aortic valve reintervention; New York Heart Association (NYHA) classification (additional data point at 6 months); change in 6-minute walk distance (6MWD) from baseline (through 1 year only); echocardiographic assessment of valve performance; clinical improvement per quality of life (QoL) instrument Kansas City Cardiomyopathy Questionnaire (KCCQ); and index hospitalization length of stay.
|
| Follow-up Visits and Length of Follow-up |
5 years
All subjects are followed at discharge or 7 days, whichever comes first, 30 days, 1 year, and annually thereafter through 5 years post procedure.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
372 patients were enrolled, of which 367 are included in the as treated population, and 365 are in the valve implant population.
|
| Actual Number of Sites Enrolled |
47
|
| Patient Follow-up Rate |
The follow-up rate through five years is approximately 87%.
|
| Final Safety Findings |
Site-Reported Safety Outcomes at 5 years:
All-cause death: 49.9%
All-stroke: 10.4%
Bleeding: 29%
Myocardial infarction: 11.8%
New permanent pacemaker: 10.6%
Atrial fibrillation: 23.8%
|
| Final Effect Findings |
Improvement in NYHA functional class was demonstrated in 85.6% of subjects at 5 years
KCCQ (change from baseline at 5 years was 31.2 -/+ 2.40 for the overall summary score and 22.6 -/+ 2.35 for the clinical summary score
Moderate or Severe Obstruction (Doppler Velocity Index < 0.25) at 5 years: 12.1%
Mean Gradient at 5 years: 16.4 mmHg
Peak Gradient at 5 years: 30.6 mmHg
Structural valve deterioration at 5 years: 3.3% (8 events, 7 subjects with the event)
|
| Study Strengths & Weaknesses |
Good THV hemodynamic valve performance was demonstrated at each follow-up visit by an improvement from baseline in mean gradient and peak gradient.
At 5 years, total and paravalvular aortic regurgitation was graded mild or less in 97.3% and 97.2% of patients, respectively.
Structural valve deterioration rates increased from 0.3% at 1 year to 3.3% at 5 years.
|
| Recommendations for Labeling Changes |
No, SAPIEN XT has been discontinued.
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