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NCT03904147 · ClinicalTrials.gov registry record · NA
TRILUMINATE Pivotal Trial
A NA study of Tricuspid Regurgitation, sponsored by Abbott Medical Devices.
- Active
- Registry status
- NA
- Development phase
- 572
- Enrollment target
- 20
- Study locations
NCT03904147: Active NA study of Tricuspid Regurgitation, sponsored by Abbott Medical Devices.
NCT03904147 is a NA study of Tricuspid Regurgitation that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 572 participants, above the 502-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (14% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03904147, a NA study of Tricuspid Regurgitation, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 572 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).
Primary Outcome
Analysis of hierarchical composite of all-cause death or tricuspid valve surgery, heart failure hospitalizations, and KCCQ improvement of at least 15 points was performed in ITT population using Finkelstein-Schoenfeld method. A win ratio was also calculated to descriptively quantify the magnitude of treatment benefits. The win ratio is calculated as the ratio of the number of wins in Device versus Control patients. The primary analysis population consisted of 175 Device patients and 175 Control
Conditions Studied
Interventions
- DEVICE TriClipTM Device
Study Locations (20)
California
- Scripps Green Hospital - La Jolla
- Cedars-Sinai Medical Center - Los Angeles
- El Camino Hospital - Mountain View
- Providence Medical Foundation (St. Joseph Hospital) - Orange
- Sutter Medical Center, Sacramento - Sacramento
- University of California - Davis Medical Center - Sacramento
- California Pacific Medical Center - San Francisco
- Los Robles Regional Medical Center - Thousand Oaks
Arizona
- St. Joseph's Hospital & Medical Center - Phoenix
- Arizona Cardiovascular Research Center - Phoenix
- Phoenix Cardiovascular Research Group - Phoenix
- Scottsdale Healthcare Shea - Scottsdale
- Tucson Medical Center - Tucson
Florida
- JFK Medical Center - Atlantis
- Manatee Memorial Hospital - Bradenton
- Morton Plant Valve Clinic - Clearwater
- Delray Medical Center - Delray Beach
Alabama
- University Hospital - University of Alabama at Birmingham - Birmingham
Colorado
- University of Colorado Hospital - Aurora
Connecticut
- Yale New Haven - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 572 participants |
| Start Date | 2019-08-21 |
| Est. Completion | 2029-04 |
| Phase | NA |
What the registry record for NCT03904147 still lists
NCT03904147 is an interventional study that assigns participants to a tested intervention. The registered 572 participants enrollment target is mid-sized for trials with a published cap, above the 502-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (14% higher).
The record links to 1 condition, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which TriClipTM Device is the first listed.
NCT03904147 names 20 study sites across 6 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT03904147 about?
NCT03904147 is a clinical study titled "TRILUMINATE Pivotal Trial". The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve ...
What is the current status of trial NCT03904147?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 572 participants. The study started on 2019-08-21. Estimated completion is 2029-04.
What conditions does trial NCT03904147 study?
This clinical trial studies the following conditions: Tricuspid Regurgitation.
What interventions are being tested in trial NCT03904147?
The interventions under investigation include: TriClipTM Device (DEVICE).
Who is sponsoring clinical trial NCT03904147?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03904147 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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 NCT03904147's enrollment target sits among peer trials
572 6th of 17 higher than 12 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
-
TTVR Early Feasibility Study
RECRUITING · NA
-
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
RECRUITING · NA
-
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
RECRUITING · NA
-
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
RECRUITING · NA
-
Trisol System EFS Study
RECRUITING · NA
-
EFS of the DUO System for Tricuspid Regurgitation
RECRUITING · NA
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