Recruiting

TTVR

Sponsor:

Medtronic Cardiovascular

Code:

NCT07321899

Conditions

Severe Tricuspid Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System

Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System

Study Details

Brief 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.

Conditions

Severe Tricuspid Regurgitation

Study ID

NCT07321899

Start date

Sep 11, 2026

Status verified date

Sep, 2026

Completion date

Apr, 2041

Anticipated

Primary completion date

Sep, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1186 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System

Transcatheter Tricuspid Valve Replacement

Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System

Transcatheter Tricuspid Valve Replacement

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Amber St Martin

612-380-5637rs.pathfinder@medtronic.com

Locations

University of Alabama at Birmingham (UAB) Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Kathy Phillips

205-975-1888kcphillips@uabmc.edu

Principal Investigator:

Mustafa Ahmed, MD

Abrazo Arizona Heart Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Jesica Byrne

602-952-0002jessica.byrne@abrazohealth.com

Principal Investigator:

Timothy Byrne, MD

Los Robles Hospital & Medical Center

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Jason Yashar

805-796-5881jason.yashar@hcahealthcare.com

Principal Investigator:

Saibal Kar, MD

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Scott Ardito

203-737-3570scott.ardito@yale.edu

Principal Investigator:

Amit Vora, MD

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Maria Kaner

404-313-6971maria.kaner@emory.edu

Elizabeth Charles

404-686-1249elizabeth.z.charles@emory.edu

Principal Investigator:

Adam Greenbaum, MD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Maggie McNamara

312-926-0846margaret.mcnamara@nm.org

Principal Investigator:

Anita Asgar, MD

Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Jennifer Nguyen

612-863-9291jennifer.nguyen@allina.com

Principal Investigator:

Konstantinos Voudris, MD

Buffalo General Medical Center

Recruiting

Buffalo, New York, United States, 14203

Contacts

Cassandra Davern

716-881-8299cadavern@buffalo.edu

Principal Investigator:

Vijay Iyer, MD

Northwell Health North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Samantha Annunziato

516-562-2653sannunziato@northwell.edu

Principal Investigator:

Bruce Rutkin, MD

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016

Contacts

Sara Hanahan

929-989-5764sara.hanahan@nyulangone.org

Principal Investigator:

Mathew Williams, MD

Montefiore Medical Center

Recruiting

New York, New York, United States, 10467

Contacts

Angela Yang

718-920-6431anyang@montefiore.org

Tammy Rodriguez Guzman

718-920-4595tamrodrigu@montefiore.org

Principal Investigator:

Azeem Latib, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Jamie Elkins

513-585-1640jamie.elkins@thechristhospital.com

Principal Investigator:

Puvi Seshiah, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Toni Zimmerman

216-444-6452zimmert5@ccf.org

Principal Investigator:

Amar Krishnaswamy, MD

More Information

Sponsor

Medtronic Cardiovascular

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Medtronic Cardiovascular on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.