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

Aug, 2026

Status verified date

Jul, 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

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

Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Jennifer Nguyen

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

Principal Investigator:

Konstantinos Voudris, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Jamie Elkins

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

Principal Investigator:

Puvi Seshiah, MD

More Information

Sponsor

Medtronic Cardiovascular

Last update posted

Jul 28, 2026

Last verified

Jul, 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 2026-09-09. This information was provided to ClinicalTrials.gov by Medtronic Cardiovascular on 2026-07-28.