Not Yet RecruitingNot Applicable

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

1,186 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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%.

What they're measuring

Rate of Major Adverse Events (MAE)

Timeframe: 30-days post-procedure

Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention

Timeframe: 1-year post-procedure

Trial details

NCT IDNCT07321899

SponsorMedtronic Cardiovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-09

Contact for this trial

Amber St Martin

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

View on ClinicalTrials.gov More Severe Tricuspid Regurgitation trials