Severe Tricuspid RegurgitationPATHFINDERNCT07321899
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
A study testing Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System and Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System in people with Severe Tricuspid Regurgitation, run by Medtronic Cardiovascular at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Tricuspid Regurgitation
- What is being tested?
- Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System and Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,186 participants
- Where
- 13 sitesUnited States
- Study dates
- 11 Sep 2026to Apr 2041
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any tricuspid device currently in place.
- Anatomic contraindications.
- Need for emergent or urgent surgery.
- Left ventricular ejection fraction <25%.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Maria Kaner, 404-313-6971, maria.kaner@emory.edu
Elizabeth Charles, 404-686-1249, elizabeth.z.charles@emory.edu
- Recruiting
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233
Kathy Phillips, 205-975-1888, kcphillips@uabmc.edu
Mustafa Ahmed, MD
- Recruiting
Buffalo General Medical Center
Buffalo, New York, 14203
Cassandra Davern, 716-881-8299, cadavern@buffalo.edu
Vijay Iyer, MD
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Maggie McNamara, 312-926-0846, margaret.mcnamara@nm.org
Anita Asgar, MD
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Jamie Elkins, 513-585-1640, jamie.elkins@thechristhospital.com
Puvi Seshiah, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Toni Zimmerman, 216-444-6452, zimmert5@ccf.org
Amar Krishnaswamy, MD
- Recruiting
Northwell Health North Shore University Hospital
Manhasset, New York, 11030
Samantha Annunziato, 516-562-2653, sannunziato@northwell.edu
Bruce Rutkin, MD
- Recruiting
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Jennifer Nguyen, 612-863-9291, jennifer.nguyen@allina.com
Konstantinos Voudris, MD
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
Scott Ardito, 203-737-3570, scott.ardito@yale.edu
Amit Vora, MD
- Recruiting
NYU Langone Medical Center
New York, New York, 10016
Sara Hanahan, 929-989-5764, sara.hanahan@nyulangone.org
Mathew Williams, MD
- Recruiting
Montefiore Medical Center
New York, New York, 10467
Angela Yang, 718-920-6431, anyang@montefiore.org
Tammy Rodriguez Guzman, 718-920-4595, tamrodrigu@montefiore.org
- Recruiting
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016
Jesica Byrne, 602-952-0002, jessica.byrne@abrazohealth.com
Timothy Byrne, MD
- Recruiting
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
Jason Yashar, 805-796-5881, jason.yashar@hcahealthcare.com
Saibal Kar, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System, Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
- Keywords
- Tricuspid Regurgitation, Symptomatic tricuspid regurgitation, Heart valve disease, Structural heart intervention, Severe valve disease, Randomized controlled trial, tricuspid insufficiency, tricuspid disease, tricuspid valve disease
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) SystemDevice
Transcatheter Tricuspid Valve Replacement
Edwards EVOQUE Tricuspid Valve Replacement (TTVR) SystemDevice
Transcatheter Tricuspid Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Medtronic Intrepid™ TTVR | Experimental | Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation. Receives: Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System |
| Edwards EVOQUE TTVR | Active comparator | Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation. Receives: Device: Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System |
| Single Arm Registry | Experimental | Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation who are not eligible for randomization. Receives: Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Adverse Events (MAE)
Measured: 30-days post-procedure
Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention
Measured: 1-year post-procedure
Secondary outcomes (7)
Tricuspid regurgitation (TR) grade reduction
Total number of patients with at least one grade TR reduction
Measured: 6 months post-procedure
Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
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
Measured: 6 months post-procedure
All-cause mortality
Measured: 12 months post-procedure
Heart failure hospitalization
Measured: 12 months post-procedure
New onset conduction disturbance (NOCD)
Measured: 30 days post-procedure
Total procedure time
Measured: Procedure
Right ventricle (RV) dysfunction
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start11 Sep 2026
- Primary completionSep 2031 (estimated)
- Study completionApr 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinayak N. Bapat, MD, Principal investigator, Minneapolis Heart InstituteAnita Asgar, MD, Principal investigator, Northwestern Medicine Bluhm Cardiovascular InstituteNicolas Dumonteil, MD, Principal investigator, Clinique Pasteur Groupe CardioVasculaire InterventionnelAzeem Latib, MD, Principal investigator, Montefiore Medical CenterFiras Zahr, MD, Principal investigator, Knight Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321899
- Sponsor's protocol ID
- MDT23032TMV006
- Acronym
- PATHFINDER
- Status last verified
- Sep 2026
- First submitted
- 5 Jan 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No