TRILUMINATE Pivotal Trial (NCT03904147)
Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: University Hospital - University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (76 Sites)
Showing the first 25 of 76 sites.
- University Hospital - University of Alabama at Birmingham — Birmingham, Alabama
- St. Joseph's Hospital & Medical Center — Phoenix, Arizona
- Arizona Cardiovascular Research Center — Phoenix, Arizona
- Phoenix Cardiovascular Research Group — Phoenix, Arizona
- Scottsdale Healthcare Shea — Scottsdale, Arizona
- Tucson Medical Center — Tucson, Arizona
- Scripps Green Hospital — La Jolla, California
- Cedars-Sinai Medical Center — Los Angeles, California
- El Camino Hospital — Mountain View, California
- Providence Medical Foundation (St. Joseph Hospital) — Orange, California
- Sutter Medical Center, Sacramento — Sacramento, California
- University of California - Davis Medical Center — Sacramento, California
- California Pacific Medical Center — San Francisco, California
- Los Robles Regional Medical Center — Thousand Oaks, California
- University of Colorado Hospital — Aurora, Colorado
- Yale New Haven — New Haven, Connecticut
- JFK Medical Center — Atlantis, Florida
- Manatee Memorial Hospital — Bradenton, Florida
- Morton Plant Valve Clinic — Clearwater, Florida
- Delray Medical Center — Delray Beach, Florida
- Baptist Hospital of Miami — Miami, Florida
- Palm Beach Garden Medical Center — Palm Beach Gardens, Florida
- Tallahassee Research Institute — Tallahassee, Florida
- Piedmont Heart Institute — Atlanta, Georgia
- Rush University Medical Center — Chicago, Illinois
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Tricuspid Regurgitation
- TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) — Phoenix, Arizona
- TTVR Early Feasibility Study — Birmingham, Alabama
- Clinical Study of Edwards Cardioband FIT Valve Repair System — Chicago, Illinois
- Laplace Early Feasibility Study - Canada — Ottawa, Ontario
- Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System — Tucson, Arizona
Explore by condition: All Tricuspid Regurgitation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.