🏛️ Verified NIH Record • Updated 2026-08-04
TTVR Early Feasibility Study (NCT04433065)
The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Medtronic Cardiovascular
🩺 Plain-English Summary (8th-Grade Level)
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham (UAB) Hospital — 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 (20 Sites)
- University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama
- Abrazo Arizona Heart Hospital — Phoenix, Arizona
- Cedars Sinai Medical Center — Los Angeles, California
- California Pacific Medical Center — San Francisco, California
- Hartford Hospital — Hartford, Connecticut
- Emory University Hospital Midtown — Atlanta, Georgia
- University of Michigan Health System - University Hospital — Ann Arbor, Michigan
- Corewell Health — Grand Rapids, Michigan
- Abbott Northwestern Hospital — Minneapolis, Minnesota
- Providence Saint Patrick Hospital — Missoula, Montana
- The Mount Sinai Hospital — New York, New York
- New York-Presbyterian Hospital Columbia University Medical Center — New York, New York
- Montefiore Medical Center — The Bronx, New York
- The Christ Hospital — Cincinnati, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- OhioHealth Riverside Methodist Hospital — Columbus, Ohio
- Oregon Health & Science University Hospital — Portland, Oregon
- UPMC Pinnacle Harrisburg Campus — Harrisburg, Pennsylvania
- Houston Methodist Hospital — Houston, Texas
- Aurora Saint Lukes Medical Center — Milwaukee, Wisconsin
💰 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
- TRILUMINATE Pivotal Trial — Birmingham, Alabama
- TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) — Phoenix, Arizona
- 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.