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

January 6, 2026 updated by: Medtronic Cardiovascular

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medtronic Intrepid™ TTVR
Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation.
Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement
Active Comparator: Edwards EVOQUE TTVR
Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation.
Device: Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement
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.
Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Major Adverse Events (MAE)
Time Frame: 30-days post-procedure
30-days post-procedure
Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention
Time Frame: 1-year post-procedure
1-year post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 12 months post-procedure
12 months post-procedure
Heart failure hospitalization
Time Frame: 12 months post-procedure
12 months post-procedure
New onset conduction disturbance (NOCD)
Time Frame: 30 days post-procedure
30 days post-procedure
Total procedure time
Time Frame: Procedure
Procedure
Right ventricle (RV) dysfunction
Time Frame: 12 months post-procedure
12 months post-procedure
Tricuspid regurgitation (TR) grade reduction
Time Frame: 6 months post-procedure
Total number of patients with at least one grade TR reduction
6 months post-procedure
Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
Time Frame: 6 months post-procedure
KCCQ overall summary score is a patient-reported measure of health status. Scores range from 0 to 100 where higher scores reflect better quality of life
6 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

  • Principal Investigator: Azeem Latib, MD, Montefiore Medical Center
  • Principal Investigator: Vinayak N. Bapat, MD, Minneapolis Heart Institute
  • Principal Investigator: Anita Asgar, MD, Northwestern Medicine Bluhm Cardiovascular Institute
  • Principal Investigator: Nicolas Dumonteil, MD, Clinique Pasteur Groupe CardioVasculaire Interventionnel
  • Principal Investigator: Firas Zahr, MD, Knight Cardiovascular Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

April 1, 2041

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Estimated)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT23032TMV006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Tricuspid Regurgitation

Clinical Trials on Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe