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NCT04097145 · ClinicalTrials.gov registry record · NA
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
A NA study of Tricuspid Regurgitation and Tricuspid Valve Disease, sponsored by Edwards Lifesciences.
- Recruiting
- Registry status
- NA
- Development phase
- 870
- Enrollment target
- 20
- Study locations
NCT04097145: Recruiting NA study of Tricuspid Regurgitation and Tricuspid Valve Disease, sponsored by Edwards Lifesciences.
NCT04097145 is a NA study of Tricuspid Regurgitation and Tricuspid Valve Disease that is actively recruiting participants, run by Edwards Lifesciences. The registered enrollment target is 870 participants, above the 485-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (79% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04097145, a NA study of Tricuspid Regurgitation and Tricuspid Valve Disease, is actively recruiting participants, sponsored by Edwards Lifesciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 870 participants
- Enrollment target
- 20
- Study locations
Study Summary
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team
Primary Outcome
Comparison of number of participants with composite endpoint events between experimental and active comparator arms
Conditions Studied
Interventions
- DEVICE Edwards PASCAL System
- DRUG Optimal Medical Therapy
Study Locations (20)
California
- University of California, Irvine - Irvine
- SCPMG - Kaiser San Diego - La Jolla
- Cedars Sinai Medical Center - Los Angeles
- UCLA Medical Center - Los Angeles
- Kaiser Permanente San Francisco - San Francisco
- University of California, San Francisco - San Francisco
- Stanford University - Stanford
Florida
- The Cardiac and Vascular Institute Research Foundation - Gainesville
- Mount Sinai Medical Center - Miami Beach
- NCH Healthcare System - Naples
- Sarasota Memorial Health Care System - Sarasota
- Tallahassee Research Institute - Tallahassee
Arizona
- Banner University Medical Center Phoenix - Phoenix
- Tucson Medical Center Healthcare - Tucson
Colorado
- St. Joseph Hospital - Denver
- Medical Center of the Rockies - Loveland
Georgia
- Emory University Hospital Midtown / Emory University - St. Joseph's Hospital - Atlanta
- Piedmont Healthcare, Inc. - Atlanta
Illinois
- Northwestern University - Chicago
Indiana
- Ascension St. Vincent Heart Center Cardiovascular Research Institute - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 870 participants |
| Start Date | 2019-12-11 |
| Est. Completion | 2031-12-31 |
| Phase | NA |
What NCT04097145 shows while recruiting
NCT04097145 is an interventional study that assigns participants to a tested intervention. The registered 870 participants enrollment target is mid-sized for trials with a published cap, above the 485-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (79% higher).
The record links to 3 conditions, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 2 interventions - of which Edwards PASCAL System is the first listed.
NCT04097145 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04097145 about?
NCT04097145 is a clinical study titled "Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial". To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with co...
What is the current status of trial NCT04097145?
This trial is currently recruiting. It is a NA study. The enrollment target is 870 participants. The study started on 2019-12-11. Estimated completion is 2031-12-31.
What conditions does trial NCT04097145 study?
This clinical trial studies the following conditions: Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency.
What interventions are being tested in trial NCT04097145?
The interventions under investigation include: Edwards PASCAL System (DEVICE), Optimal Medical Therapy (DRUG).
Who is sponsoring clinical trial NCT04097145?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04097145 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tricuspid Regurgitation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04097145's enrollment target sits among peer trials
870 4th of 17 higher than 14 of 17 other Tricuspid Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tricuspid Regurgitation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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