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NCT02744677 · ClinicalTrials.gov registry record · NA
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
A NA study of Complex Congenital Heart Defect and Pulmonary Valve Insufficiency, sponsored by Edwards Lifesciences.
- Recruiting
- Registry status
- NA
- Development phase
- 108
- Enrollment target
- 20
- Study locations
NCT02744677: Recruiting NA study of Complex Congenital Heart Defect and Pulmonary Valve Insufficiency, sponsored by Edwards Lifesciences.
NCT02744677 is a NA study of Complex Congenital Heart Defect and Pulmonary Valve Insufficiency that is actively recruiting participants, run by Edwards Lifesciences. The registered enrollment target is 108 participants, roughly in line with the 115-participant average among 3 other Complex Congenital Heart Defect trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02744677, a NA study of Complex Congenital Heart Defect and Pulmonary Valve Insufficiency, is actively recruiting participants, sponsored by Edwards Lifesciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.
Primary Outcome
Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient \> 40 mmHg via TTE
Conditions Studied
Interventions
- DEVICE SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
- DEVICE SAPIEN 3 THV
- DEVICE SAPIEN 3 Ultra RESILIA THV
Study Locations (20)
Ohio
- The Lindner Research Center at Christ Hospital - Cincinnati
- Cincinnati Children's Hospital - Cincinnati
- Nationwide Children's Hospital - Columbus
California
- University of California, Los Angeles - Los Angeles
- University of California,, San Francisco (UCSF) - San Francisco
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Children's Hospital - Boston
Missouri
- St. Louis Children's Hospital - St Louis
- Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital - St Louis
Pennsylvania
- Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia - Philadelphia
- UPMC Children's Hospital of Pittsburgh - Pittsburgh
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Childrens Hospital of Colorado - Aurora
Georgia
- Emory University/Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2016-07-05 |
| Est. Completion | 2031-06 |
| Phase | NA |
What NCT02744677 shows while recruiting
NCT02744677 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 115-participant average among 3 other Complex Congenital Heart Defect trials with a reported enrollment target.
The record links to 4 conditions, with Complex Congenital Heart Defect appearing as the primary indexed condition, and to 3 interventions - of which SAPIEN 3/SAPIEN 3 Ultra RESILIA THV is the first listed.
NCT02744677 names 20 study sites across 14 states, led by Ohio, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02744677 about?
NCT02744677 is a clinical study titled "COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction". This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a c...
What is the current status of trial NCT02744677?
This trial is currently recruiting. It is a NA study. The enrollment target is 108 participants. The study started on 2016-07-05. Estimated completion is 2031-06.
What conditions does trial NCT02744677 study?
This clinical trial studies the following conditions: Complex Congenital Heart Defect, Pulmonary Valve Insufficiency, Dysfunctional RVOT Conduit, Pulmonary Valve Degeneration.
What interventions are being tested in trial NCT02744677?
The interventions under investigation include: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV (DEVICE), SAPIEN 3 THV (DEVICE), SAPIEN 3 Ultra RESILIA THV (DEVICE).
Who is sponsoring clinical trial NCT02744677?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02744677 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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