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NCT05378386 · ClinicalTrials.gov registry record
ALTERRA Post-Approval Study
A clinical trial of Tetralogy of Fallot and Pulmonary Regurgitation, sponsored by Edwards Lifesciences.
- Active
- Registry status
- 150
- Enrollment target
- 20
- Study locations
NCT05378386: Active study of Tetralogy of Fallot and Pulmonary Regurgitation, sponsored by Edwards Lifesciences.
NCT05378386 is a study of Tetralogy of Fallot and Pulmonary Regurgitation that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 150 participants, below the 168-participant average among 7 other Tetralogy of Fallot trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05378386, a study of Tetralogy of Fallot and Pulmonary Regurgitation, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
Primary Outcome
Acute Device Success, defined as a non-hierarchical composite of: * Single Alterra deployed in the desired location * Single THV implanted in the desired location within Alterra * Right ventricle-pulmonary artery peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram * Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation
Conditions Studied
Interventions
- DEVICE Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
Study Locations (20)
California
- Cedars Sinai Medical Center - Los Angeles
- Rady Children's Hospital - San Diego
- Stanford University - Stanford
Florida
- UF Health Shands Hospital - Gainesville
- St. Joseph's Children's Hospital - Tampa
New York
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University - New York
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Nationwide Children's Hospital - Columbus
Texas
- Medical City Dallas - Dallas
- Children's Memorial Hermann Hospital - Houston
Alabama
- Children's of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Colorado Children's Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-05-12 |
| Est. Completion | 2035-07 |
What the registry record for NCT05378386 still lists
NCT05378386 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 168-participant average among 7 other Tetralogy of Fallot trials with a reported enrollment target (11% lower).
The record links to 5 conditions, with Tetralogy of Fallot appearing as the primary indexed condition, and to 1 intervention - of which Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System is the first listed.
NCT05378386 names 20 study sites across 14 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT05378386 about?
NCT05378386 is a clinical study titled "ALTERRA Post-Approval Study". This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
What is the current status of trial NCT05378386?
This trial is currently active not recruiting. The enrollment target is 150 participants. The study started on 2022-05-12. Estimated completion is 2035-07.
What conditions does trial NCT05378386 study?
This clinical trial studies the following conditions: Tetralogy of Fallot, Pulmonary Regurgitation, Complex Congenital Heart Defect, Pulmonary Valve Insufficiency, RVOT Anomaly.
What interventions are being tested in trial NCT05378386?
The interventions under investigation include: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System (DEVICE).
Who is sponsoring clinical trial NCT05378386?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05378386 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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