|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P130021 S058/ PAS001 |
| Date Original Protocol Accepted |
08/16/2019
|
| Date Current Protocol Accepted |
12/23/2023
|
| Study Name |
Cont fu of Evolut R & PRO Sys Low Risk cohort PAS
|
| Device Name |
Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System
|
| Clinical Trial Number(s) |
NCT02701283
|
| 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, 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 |
Safety Results
AT Population:
¿ All-cause mortality: 13.5% (TAVR) vs. 14.9% (SAVR)
¿ Cardiovascular mortality: 7.2% vs. 9.3%
¿ All stroke: 9.5% vs. 8.6%
¿ Disabling stroke: 3.6% vs 4.0%
¿ Reintervention: 3.3% vs. 2.5%
¿ Leaflet motion abnormality or valve thrombosis:
3.1% vs. 1.8%
¿ Valve endocarditis: 1.4% vs. 2.5%
¿ Aortic valve hospitalization: 13.9% vs. 15.1%
¿ Permanent pacemaker implantation: 27.0% vs.
11.3%
¿ Coronary artery obstruction: 0.8% vs. 0.3%
¿ Myocardial infarction: 6.0% vs. 3.6%
Effectiveness Results
Implanted Population:
¿ Prosthetic valve dysfunction: 2.3% vs. 1.0%
o =moderate total aortic regurgitation: 1.3% vs. 0.3%
o Moderate or severe aortic valve stenosis:
0.8% vs. 0.6%
¿ Mean gradient: 10.69 ± 6.56 vs. 12.81 ± 6.91 mmHg
¿ EOA: 2.07 ± 0.62 vs. 1.89 ± 0.63 cm2
¿ Total aortic regurgitation (>=moderate): 1.3% vs. 0.3%
AT Population:
¿ NYHA I/II: 97.7% vs. 97.2% (evaluable patients only)
¿ KCCQ: 88.3 ± 15.8 vs. 88.5 ± 15.8
|
| Actual Number of Patients Enrolled |
1478 enrolled; 737 TAVR and 741 SAVR
|
| Actual Number of Sites Enrolled |
87
|
| Patient Follow-up Rate |
At 60 months (all ITT patients evaluated): 92.9% vs. 79.9%
|
