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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130009 / PAS001 |
| Date Original Protocol Accepted |
06/16/2014
|
| Date Current Protocol Accepted |
08/02/2016
|
| Study Name |
Cont F/U of the IDE inop pts cohort(B)
|
| Device Name |
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Objective: To study the long term (5 year) device safety and effectiveness in continued follow-up of cohort B and six nested registries.
Design: A continued follow-up of Cohort B and six nested registries in IDE pivotal study, a prospective randomized, multi-center trial with two population cohorts undergoing transcatheter heart valve replacement therapy with SAPIEN XT THV.
Subjects will be all pivotal and CAP Patients enrolled in Cohort B and six nested registries (NR1, NR4, NR5, NR6) and who are not suitable for aortic valve surgery (i.e. inoperable patients).
|
| Study Population |
all pivotal and CAP Patients enrolled in Cohort B and four nested registries (NR1, NR4, NR5, NR6)
|
| Sample Size |
Currently, a total of 1790 patients from pivotal trials (560 from Cohort B and 1230 from the six registries) and 775 continued access (CAP) patients from the six nested registries (as of June 2, 2014) are available for continued follow-up.
|
| Key Study Endpoints |
Through TVT-Registry
|
| Follow-up Visits and Length of Follow-up |
Subjects will be followed annually through 5 years. Patients have been consented for up to 5 years follow-up, thus no re-consent is needed.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1042
|
| Actual Number of Sites Enrolled |
54
|
| Patient Follow-up Rate |
5-year follow-up rate of 94.7%
|
| Final Safety Findings |
The 5-year CEC adjudicated KM rate was 51.3% for all-cause death and stroke, 46.0% for all-cause death, 15.4% for all-stroke, and 33.4% for rehospitalization for symptoms of aortic stenosis and/or complications of the valve procedure.
|
| Final Effect Findings |
Patients showed persistent improvement from baseline in:
1. NYHA functional classification (80.7% of patients at 5 years)
2. KCCQ (change from baseline at 5 years was 15.9 +/- 1.3 for the overall summary score and 8.5 +/- 1.3
for the clinical summary score)
3. EQ-5D VAS score (change from baseline at 5 years: 6.5 +/- 1.4)
|
| Study Strengths & Weaknesses |
Good THV hemodynamic valve performance was demonstrated at each follow-up visit by an improvement from baseline in EOA, mean gradient and peak gradient. At 5 years, the proportion of patients with moderate or greater total aortic regurgitation and paravalvular regurgitation was 7.6% and 6.4%, respectively.
|
| Recommendations for Labeling Changes |
no need to update the labeling based on the results of the 5-year follow-up for the PIIB NR1, NR2, NR4, NR5, and NR6.
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