NCT07321899

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

Transcatheter Tricuspid Valve Replacement Using the Medtronic Intrepid™ TTVR System in Patients With Severe Symptomatic Tricuspid Regurgitation - PATHFINDER

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,186 (estimated)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System	Transcatheter Tricuspid Valve Replacement
DEVICE	Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System	Transcatheter Tricuspid Valve Replacement

Timeline

• Start date: 2026-06-01
• Primary completion: 2031-09-01
• Completion: 2041-04-01
• First posted: 2026-01-07
• Last updated: 2026-01-08

Regulatory

• FDA-regulated device study