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NCT04860765 · ClinicalTrials.gov registry record
COMPASSION S3 Post-Approval Study
A clinical trial of Complex Congenital Heart Defect and Pulmonary Valve Insufficiency, sponsored by Edwards Lifesciences.
- Active
- Registry status
- 150
- Enrollment target
- 19
- Study locations
NCT04860765: Active study of Complex Congenital Heart Defect and Pulmonary Valve Insufficiency, sponsored by Edwards Lifesciences.
NCT04860765 is a study of Complex Congenital Heart Defect and Pulmonary Valve Insufficiency that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 150 participants, above the 101-participant average among 3 other Complex Congenital Heart Defect trials with a reported enrollment target (49% higher). The trial reports 19 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04860765, a study of Complex Congenital Heart Defect and Pulmonary Valve Insufficiency, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 19
- Study locations
Study Summary
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
Primary Outcome
Defined as a composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery peak-to-peak gradient \< 35 mmHg post-implantation * Less than moderate PR by discharge TTE * Free of explant at 24 hours post-implantation
Conditions Studied
Interventions
- DEVICE SAPIEN 3 THV
Study Locations (19)
New York
- Mount Sinai - New York
- Columbia University Medical Center/NYPH - New York
Ohio
- Cincinatti Children's Hospital - Cincinnati
- Nationwide Children's Hospital - Columbus
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Texas
- Dell Children's - Austin
- Children's Health Dallas - Dallas
Alabama
- University of Alabama - Birmingham
California
- Cedars Sinai - Los Angeles
Colorado
- Children's Hospital of Colorado - Aurora
Illinois
- Advocate Childrens Hospital - Oak Lawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-04-13 |
| Est. Completion | 2030-08 |
What the registry record for NCT04860765 still lists
NCT04860765 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, above the 101-participant average among 3 other Complex Congenital Heart Defect trials with a reported enrollment target (49% higher).
The record links to 5 conditions, with Complex Congenital Heart Defect appearing as the primary indexed condition, and to 1 intervention - of which SAPIEN 3 THV is the first listed.
NCT04860765 lists 19 locations in 15 states (New York, Ohio, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT04860765 about?
NCT04860765 is a clinical study titled "COMPASSION S3 Post-Approval Study". This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
What is the current status of trial NCT04860765?
This trial is currently active not recruiting. The enrollment target is 150 participants. The study started on 2021-04-13. Estimated completion is 2030-08.
What conditions does trial NCT04860765 study?
This clinical trial studies the following conditions: Complex Congenital Heart Defect, Pulmonary Valve Insufficiency, Dysfunctional RVOT Conduit, Pulmonary Valve Degeneration, Pulmonary Valve; Obstruction.
What interventions are being tested in trial NCT04860765?
The interventions under investigation include: SAPIEN 3 THV (DEVICE).
Who is sponsoring clinical trial NCT04860765?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04860765 being conducted?
This trial has 19 study locations across Alabama, California, Colorado, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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