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

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

Recruiting
18 years and older
All
Phase N/A
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Overview

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.

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

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%.

Study details
    Severe Tricuspid Regurgitation

NCT07321899

Medtronic Cardiovascular

20 October 2026

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