NCT07321899NARecruiting

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

Medtronic Cardiovascular

Start Date

8/1/2026

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

Abrazo Arizona Heart Hospital

Phoenix, Arizona 85016

United States

Los Robles Hospital & Medical Center

Thousand Oaks, California 91360

United States

Abbott Northwestern Hospital

Minneapolis, Minnesota 55407

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States