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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03904147
The ClinicalTrials.gov registry entry for NCT03904147 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 572 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 502-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (14% higher). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.