|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P130009 S037/ PAS002 |
| Date Original Protocol Accepted |
09/20/2016
|
| Date Current Protocol Accepted |
04/03/2017
|
| Study Name |
New Enrollment SAPIEN XT Pulmonic PAS
|
| Device Name |
SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
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 |
To evaluate longer-term safety and effectiveness of the SAPIEN XT Transcatheter Heart Valve (THV) in the pulmonic position for the intended patient population (especially pediatric) when used as indicated with all valve sizes (SAPIEN XT THV 23, 26, 29 mm). Single-arm, prospective, multicenter post-approval study using a performance goal based on the original COMPASSION trial.
|
| Study Population |
Pediatric and adult patients with a dysfunctional, non- compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention and:
• pulmonary regurgitation = moderate and/or
• mean RVOT gradient = 35 mmHg.
|
| Sample Size |
A total of 191 patients will be enrolled at up to 20 sites in the US.
|
| Key Study Endpoints |
Primary:
Freedom from device- or procedure-related death or reintervention at 1 year
Secondary:
Improved valve hemodynamics at 30 days, 1 year, 2 years and annually through 5 years as demonstrated via transthoracic echocardiogram (TTE):
a) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions
b) Decrease in RVOT mean gradient to less than 30mmHg for stenotic lesions
c) Improvement in both a) and b) above for mixed lesions.
Improvement of = 1 NYHA functional class from baseline for patients with NYHA functional class = 2 at baseline.
Recurrent pulmonary stenosis, defined as RVOT peak gradient greater than or equal to 36 mmHg at 30 days, 1 year, 2 years and annually through 5 years as demonstrated via TTE for patients with stenosis at baseline (RVOT peak gradient = 36 mmHg at baseline).
Device Success, defined as a composite of:
a) Deployment of the valve to the target area, and
b) Removal of the delivery catheter out of the body, and
c) Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE.
Safety:
MACCE at 30 days and 1 year, defined as a composite of death, myocardial infarction, reintervention, vascular injury resulting in the need for an unplanned vascular intervention, stroke and pulmonary embolism
|
| Follow-up Visits and Length of Follow-up |
5 years
|
