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

Covidien

Status: Begins enrollment in 3 months

Conditions: Severe Tricuspid Regurgitation

Treatments: Device: Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System; Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07321899

MDT23032TMV006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,186 participants in 3 patient groups

Medtronic Intrepid™ TTVR

Experimental group

Description:

Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation.

Treatment:

Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System

Edwards EVOQUE TTVR

Active Comparator group

Description:

Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation.

Treatment:

Device: Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System

Single Arm Registry

Experimental group

Description:

Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation who are not eligible for randomization.

Treatment:

Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System