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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 yrs < 12 yrs,
Adolescent: 13-18 yrs,
Transit.Adolescent A (distinctively):18 yrs<22 yrs,
Adult: At least 22 yrs
|
| 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, 1-year): 98.1%
Freedom from RVOT/PV reintervention (1-years): 100.0%
Alterra pre-stent fracture (1-year Kaplan-Meier rate): 8.6%
Sapien 3 valve frame fracture (1-year Kaplan-Meier rate): 0.0%
Effectiveness Results:
Acute device success
Device success: 96.7% (118/122)
Single Alterra pre-stent deployed in desired location: 97.8% (134/137)
Single Sapien 3 valve implanted in desired location within Alterra 97.1% (133/137)
RV-PA peak-to-peak gradient < 35 mmHg post implant: 100% (130/130)
Less that moderate PR by discharge TTE: 100% (121/121)
Free of explant at 24 hours post-implantation: 100% (134/134)
Mean RVOT gradient
baseline – 7.3 mmHg; 30 days – 7.6 mmHg
Total pulmonic regurgitation
30 days: None – 69.6% (78/112); Trace – 8.9% (10/112); Mild – 21.4% (24/112); Moderate – 0.0% (0/112); Severe – 0.0% (0/112)
Paravalvular regurgitation
30 days: None – 95.5% (107/112); Trace - 0.9% (1/112); Mild – 3.6% (4/112); Moderate – 0.0% (0/112); Severe – 0.0% (0/112)
Tricuspid regurgitation
30 days: None – 1.8% (2/112); Trace – 23.2% (26/112); Mild – 53.6% (60/112); Moderate – 17% (19/112); Severe – 4.5% (5/112)
Change in NYHA from baseline
30 days: Improved – 42.9% (51/119); Same – 52.9% (63/119); Worsened – 4.2% (5/119)
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| Actual Number of Patients Enrolled |
Enrolled: 150; Valve implanted: 134
|
| Actual Number of Sites Enrolled |
22
|
| Patient Follow-up Rate |
At 30 days, 125 subjects out of 134 subjects with the study devices implanted had known status (93.3%).
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