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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200015 S011/ PAS002 |
| Date Original Protocol Accepted |
12/16/2021
|
| Date Current Protocol Accepted |
03/03/2023
|
| Study Name |
Alterra New Enrollment Study
|
| Device Name |
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
|
| Clinical Trial Number(s) |
NCT03130777
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multi-center, single-arm new enrollment study. The objective of the study is to characterize the real-world performance of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Edwards Alterra Adaptive Prestent through 10 years post implant.
|
| Study Population |
Patients with severe pulmonary regurgitation who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement.
|
| Sample Size |
150
|
| Key Study Endpoints |
Acute device success, transcatheter heart valve dysfunction, echocardiographic assessments, New York Heart Association (NYHA) functional class, and adverse events device (including device frame fracture).
|
| Follow-up Visits and Length of Follow-up |
10 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Freedom from death (with vital status, 30-days): 100.0%
Freedom from RVOT/PV reintervention (1-years): 100.0%
Alterra pre-stent fracture (1-year Kaplan-Meier rate): 12.3%
Sapien 3 valve frame fracture (1-year Kaplan-Meier rate): 0.0%
Effectiveness Results:
Acute device success
Device success: 93.6% (73/78)
Single Alterra pre-stent deployed in desired location: 96.9% (95/98)
Single Sapien 3 valve implanted in desired location within Alterra (94.9% (93/98)
RV-PA peak-to-peak gradient < 35 mmHg post implant: 100% (94/94)
Less that moderate PR by discharge TTE: 100% (74/74)
Free of explant at 24 hours post-implantation: 100% (94/94)
Mean RVOT gradient
baseline – 8.1 mmHg; 30 days – 7.9 mmHg
Total pulmonic regurgitation
30 days: None – 65.6% (42/64); Trace – 6.3% (4/64); Mild – 28.1% (18/64); Moderate – 0.0% (0/64); Severe – 0.0% (0/64)
Paravalvular regurgitation
30 days: None – 96.9% (62/64); Trace - 0.0% (0/64); Mild – 3.1% (2/64); Moderate – 0.0% (0/64); Severe – 0.0% (0/64)
Tricuspid regurgitation
30 days: None – 3.1% (2/64); Trace – 26.6% (17/64); Mild – 56.3% (36/64); Moderate – 10.9% (7/64); Severe – 3.1% (2/64)
Change in NYHA from baseline
30 days: Improved – 40.7% (35/86); Same – 53.5% (46/86); Worsened – 5.8% (5/86)
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| Actual Number of Patients Enrolled |
Enrolled: 108; Valve implanted: 94
|
| Actual Number of Sites Enrolled |
17
|
| Patient Follow-up Rate |
At 30 days, 93 subjects (93 alive, 0 dead) out of 94 subjects with the study devices implanted had known status (98.9%).
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