|
General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P140031 S085/ PAS001 |
Date Original Protocol Accepted |
08/16/2019
|
Date Current Protocol Accepted |
 
|
Study Name |
Cont f/u of SAPIEN 3 Low Risk cohort PAS
|
Device Name |
SAPIEN 3 Ultra transcatheter heart valve
|
Clinical Trial Number(s) |
NCT02675114
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
Concurrent Control
|
Analysis Type |
Descriptive
|
Study Population |
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
Continued follow-up of all living subjects who were enrolled in the pivotal cohort under the IDE. The objective of this study is to characterize the clinical outcomes annually through 10 years post-procedure.
|
Study Population |
All living subjects who were enrolled in the IDE pivotal cohort.
|
Sample Size |
All living subjects.
|
Key Study Endpoints |
All-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, requirement for renal replacement, coronary artery obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure, new permanent pacemaker implantation, prosthetic valve endocarditis, prosthetic valve thrombosis, New York Heart Association (NYHA) classification, 6-Minute Walk Test (6MWT) distance, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and hemodynamic performance metrics by Doppler echocardiography.
|
Follow-up Visits and Length of Follow-up |
10 years
|
Interim or Final Data Summary |
Interim Results |
At 6 years: All-cause mortality (including vital status check): 14.6% (TAVR); 11.9% (SAVR) Stroke: 7.2% (TAVR); 6.6% (SAVR) Aortic valve reintervention: 3.6% (TAVR); 3.6% (SAVR) NYHA (% in class I/II): 94.9% (TAVR); 93.9% (SAVR) KCCQ (Mean Change from Baseline): 13.2 (TAVR); 14.6 (SAVR)
At 5 years: Transvalvular mean gradient: 12.8 (TAVR); 11.7 (SAVR) Effective orifice area: 1.9 (TAVR); 1.8 (SAVR) Greater than or equal to Moderate Total Aortic Regurgitation: 1.8% (TAVR); 0.3% (SAVR) Greater than or equal to Moderate PVL: 0.9% (TAVR); 0.0% (SAVR)
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Actual Number of Patients Enrolled |
1,000 randomized subjects; 948 implanted (495 TAVR & 453 SAVR)
|
Actual Number of Sites Enrolled |
71
|
Patient Follow-up Rate |
At 6 years (patient status known): 89% (TAVR); 82% (SAVR)
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