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

Conditions

• Severe Tricuspid Regurgitation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System — DEVICE
  Transcatheter Tricuspid Valve Replacement
• Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System — DEVICE
  Transcatheter Tricuspid Valve Replacement

Study Details

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.

Key Dates

First listed

Jan 7, 2026

Start date

Aug 31, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2031

Completion

Apr 30, 2041

Study Design

Enrollment

1,186 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Medtronic Intrepid™ TTVR
  Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation.
• Active Comparator: Edwards EVOQUE TTVR
  Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation.
• Experimental: Single Arm Registry
  Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation who are not eligible for randomization.

Primary Outcome Measure

Rate of Major Adverse Events (MAE) [ Time Frame: 30-days post-procedure ]

Central Contacts

• Amber St Martin
  612-380-5637
  [email protected]

Locations (4)

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