|
General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P130021 S033/ PAS001 |
Date Original Protocol Accepted |
07/10/2017
|
Date Current Protocol Accepted |
12/23/2023
|
Study Name |
Cont f/u Intermediate Risk Cohort
|
Device Name |
CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System
|
Clinical Trial Number(s) |
NCT01586910
|
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 SURTAVI trial under the IDE (G120169). The objective of this PAS is to characterize the clinical outcomes annually through 10 years post-procedure.
|
Study Population |
All living subjects who were enrolled in the IDE
|
Sample Size |
All living subjects
|
Key Study Endpoints |
The key safety and effectiveness endpoints include all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, acute kidney injury at stage 2 or 3, 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, 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 84 months: All-cause mortality: 46.4% (TAVR); 43% (SAVR) All stroke: 15% (TAVR); 16.4% (SAVR) TIA: 9.5% (TAVR); 6.1% (SAVR) MI: 8.9% (TAVR); 5.6% (SAVR) Valve-related dysfunction requiring repeat procedure: 5.6% (TAVR); 2.7% (SAVR) New permanent pacemaker implantation: 41.9% (TAVR); 18.3% (SAVR) Prosthetic valve endocarditis: 2.9% (TAVR); 2.6% (SAVR) Prosthetic valve thrombosis: 1.2% (TAVR); 0.8% (SAVR) NYHA Mean Change from Baseline: -0.9 (TAVR); -1.1 (SAVR) Transvalvular mean gradient (site reported): 9.47 (TAVR); 11.87 (SAVR) Mean Effective orifice area (site reported): 1.91 (TAVR); 1.59 (SAVR) Greater than or equal to Moderate Total Aortic Regurgitation (site reported): 9.1% (TAVR); 4.2% (SAVR)
|
Actual Number of Patients Enrolled |
1746 enrolled; 1660 attempted implanted (864 TAVR and 796 SAVR)
|
Actual Number of Sites Enrolled |
87
|
Patient Follow-up Rate |
At 84 months (patient status known): TAVR: 84% SAVR: 75%
|