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Medtronic Intrepid™ TTVR System for Severe Tricuspid Regurgitation

This study is looking at the safety and effectiveness of two devices, the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System and the Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System, for people with severe tricuspid regurgitation. Tricuspid regurgitation means the heart's tricuspid valve isn't closing properly, causing blood to leak backward. To join, you must be at least 18 years old and have severe symptoms despite other treatments. Your heart care team must also agree that this type of valve replacement is right for you. The study will measure how many major problems occur within 30 days and a combination of outcomes like death, hospital stays for heart failure, or needing another tricuspid valve procedure within one year. The current status of this study is unclear.

Study design
This is a large, randomized controlled study comparing two different devices, planning to enroll 1186 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one year after the procedure to assess outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07321899

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

Recruiting
NAAges 18+InterventionalTreatment
Medtronic Cardiovascular
~1,186 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) SystemEdwards EVOQUE Tricuspid Valve Replacement (TTVR) System

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Major Adverse Events (MAE)
Measured over 30-days post-procedure
+1 more outcome measured

Conditions

Severe Tricuspid Regurgitation

Explore related trials

Tricuspid Valve Insufficiency

Where it's being run

4 sites across 4 states
Arizona1
California1
Minnesota1
Ohio1

Study leadership

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

Who to contact

Amber St Martin
[email protected]
612-380-5637
Email the study team

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Eligibility criteria

Inclusion

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

Any tricuspid device currently in place.
Anatomic contraindications.
Need for emergent or urgent surgery.
Left ventricular ejection fraction \<25%.

What this trial measures

  • Rate of Major Adverse Events (MAE)30-days post-procedure
  • Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention1-year post-procedure