TTVR Early Feasibility Study

Running, not enrolling · Not applicable

Conditions studied: Tricuspid Regurgitation

In brief

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.

Key facts

Study ID: NCT04433065
Run by: Medtronic Cardiovascular
People needed: 150
Starts: 2020-10-20
Expected to finish: 2031-08-26
Last updated by the study team: 2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
New York Heart Association (NYHA) Function Class II or greater
Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

You may not qualify if…

Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
Echocardiographic evidence of severe right ventricular dysfunction
Left ventricular ejection fraction (LVEF) <30 as measured by resting echocardiogram within 30 days of the Index Procedure
Need for emergent or urgent surgery
Untreated clinically significant coronary artery disease requiring revascularization
Carcinoid tricuspid regurgitation

Where it is running

University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States
Abrazo Arizona Heart Hospital — Phoenix, Arizona, United States
Cedars Sinai Medical Center — Los Angeles, California, United States
California Pacific Medical Center — San Francisco, California, United States
Hartford Hospital — Hartford, Connecticut, United States
Emory University Hospital Midtown — Atlanta, Georgia, United States
University of Michigan Health System - University Hospital — Ann Arbor, Michigan, United States
Corewell Health — Grand Rapids, Michigan, United States
Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
Providence Saint Patrick Hospital — Missoula, Montana, United States
The Mount Sinai Hospital — New York, New York, United States
New York-Presbyterian Hospital Columbia University Medical Center — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
The Christ Hospital — Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
OhioHealth Riverside Methodist Hospital — Columbus, Ohio, United States
Oregon Health & Science University Hospital — Portland, Oregon, United States
UPMC Pinnacle Harrisburg Campus — Harrisburg, Pennsylvania, United States
Houston Methodist Hospital — Houston, Texas, United States
Aurora Saint Lukes Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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