NCT07321899NARecruiting

Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation

Medtronic Cardiovascular

Start Date

9/11/2026

Completion Date

4/1/2041

Summary

This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.

Detailed Description

Prospective, global, pre-market, interventional, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age ≥18 years at the time of consent. * Severe symptomatic tricuspid regurgitation (TR) despite optimal medical therapy (OMT). * Local site multidisciplinary heart team experienced in tricuspid valve therapies agrees that the subject is appropriate for TTVR. Exclusion Criteria: * Any tricuspid device currently in place. * Anatomic contraindications. * Need for emergent or urgent surgery. * Left ventricular ejection fraction \<25%.

Interventions

DEVICE

Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System

DEVICE

Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System

Interested in This Trial?

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Conditions

Severe Tricuspid Regurgitation

Locations

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama 35233

United States

Abrazo Arizona Heart Hospital

Phoenix, Arizona 85016

United States

Los Robles Hospital & Medical Center

Thousand Oaks, California 91360

United States

Yale New Haven Hospital

New Haven, Connecticut 06510

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

Abbott Northwestern Hospital

Minneapolis, Minnesota 55407

United States

Buffalo General Medical Center

Buffalo, New York 14203

United States

Northwell Health North Shore University Hospital

Manhasset, New York 11030

United States

NYU Langone Medical Center

New York, New York 10016

United States

Montefiore Medical Center

New York, New York 10467

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States