|
General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P200015 / PAS001 |
Date Original Protocol Accepted |
08/06/2020
|
Date Current Protocol Accepted |
 
|
Study Name |
SAPIEN 3 Pulmonic Long Term F/u Study
|
Device Name |
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
|
Clinical Trial Number(s) |
NCT02744677
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
Continued follow-up of all living subjects enrolled under IDE G150220, including the Continued Access Protocol subjects. The objective of this study is to characterize the clinical outcomes of these subjects annually through 5 years post-procedure.
|
Study Population |
All living subjects enrolled under IDE G150220, including the Continued Access Protocol subjects.
|
Sample Size |
All living subjects.
|
Key Study Endpoints |
Mortality, transcatheter heart valve (THV) dysfunction, THV hemodynamic function, THV frame fracture, and device-related endocarditis.
|
Follow-up Visits and Length of Follow-up |
5 years
|
Interim or Final Data Summary |
Interim Results |
Safety Results At 5 years: THV dysfunction: 13% (6/46) RVOT reintervention: 5% (3/60) Moderate or greater PR: 4.4% (2/45) Mean RVOT gradient >40 mmHg: 2.2% (1/45) Freedom from Death with Vital Sweep: 98.6% Freedom from Valve Frame Facture: 100% Freedom from Device-related Endocarditis: 95.5%
Effectiveness results: Mean RVOT gradient: Baseline: 27.4 mmHg; 1-year: 13.2 mmHg; 5-year: 14.5 mmHg Peak RVOT gradient: Baseline: 47.5 mmHg; 1-year: 23.3 mmHg; 5-year: 24.9 mmHg Paravalvular Regurgitation: 5-year: None – 95.6% (43/45); Trace – 2.2% (1/45); Mild – 2.2% (1/45) Total pulmonary regurgitation: 5-year: Improved – 88.9% (40/45); Worsened – 2.2% (1/45); Stayed the same – 6.7% (3/45)
|
Actual Number of Patients Enrolled |
72 total subjects in main cohort and 14 in CAP were enrolled. 56 in main and 13 in CAP were implanted.
|
Actual Number of Sites Enrolled |
11
|
Patient Follow-up Rate |
At 5 years, 52 subjects (with known status) of 69 total subjects that have reached 5-year follow up results in a 52/69 (75%) 5-year follow-up rate at this time.
|