Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation with TTVR Systems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, global, pre-market, interventional, multi-center, randomized pivotal trial comparing the Medtronic Intrepid Transcatheter Tricuspid Valve Replacement system to the Edwards EVOQUE system in adults with severe or greater tricuspid regurgitation. Participants are adults with symptoms despite optimal medical therapy and are evaluated by a multidisciplinary heart team for suitability. The study aims to assess safety and effectiveness of the two transcatheter tricuspid valve replacement approaches in a real-world, clinical setting. Enrollment is limited to centers with tricuspid valve expertise, and the trial excludes patients with certain anatomic contraindications or severe left ventricular dysfunction. Outcomes will inform potential regulatory approval and future use in this patient population.

Why it matters

Who can join: the full rules

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%.

Where it's running

• University of Alabama at Birmingham (UAB) Hospital
  Birmingham, Alabama, United States Recruiting
• Abrazo Arizona Heart Hospital
  Phoenix, Arizona, United States Recruiting
• Los Robles Hospital & Medical Center
  Thousand Oaks, California, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Emory University Hospital Midtown
  Atlanta, Georgia, United States Recruiting
• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Vinayak N. Bapat, MD — Minneapolis Heart Institute
• Study coordinator: Amber St Martin
• Email: rs.pathfinder@medtronic.com
• Phone: 612-380-5637

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

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• Transcatheter tricuspid valve clipping for severe tricuspid regurgitation

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  Recruiting Shanghai Huihe Medical Technology Co., Ltd · Shanghai · NCT07433504

• Transcatheter tricuspid repair or replacement with implanted pulmonary-artery pressure monitoring

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  Recruiting LMU Klinikum · Munich and 1 other locations · NCT07442903

• First-in-man TRICENTO G2 Transcatheter Valve for Tricuspid Regurgitation

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• 3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.