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Clinical Trials in the USA / NCT07321899
Recruiting Not applicable

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

NCT07321899 · tracked via the Priya Life Science USA tracker
Sponsor
Medtronic Cardiovascular
Phase
Not applicable
Started
2026-09-11
Last updated
2026-09-25

Condition(s) studied

Severe Tricuspid Regurgitation

Investigational drug(s) / intervention(s)

Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) SystemEdwards EVOQUE Tricuspid Valve Replacement (TTVR) System

Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System: Transcatheter Tricuspid Valve Replacement

Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System: Transcatheter Tricuspid Valve Replacement

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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%.

Primary outcome measure(s)

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

Trial sites (13)

FacilityCityRegionStatus
University of Alabama at Birmingham (UAB) Hospital Birmingham Alabama Recruiting
Abrazo Arizona Heart Hospital Phoenix Arizona Recruiting
Los Robles Hospital & Medical Center Thousand Oaks California Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
Emory University Hospital Midtown Atlanta Georgia Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
Abbott Northwestern Hospital Minneapolis Minnesota Recruiting
Buffalo General Medical Center Buffalo New York Recruiting
Northwell Health North Shore University Hospital Manhasset New York Recruiting
NYU Langone Medical Center New York New York Recruiting
Montefiore Medical Center New York New York Recruiting
The Christ Hospital Cincinnati Ohio Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting

More Medtronic Cardiovascular trials in the USA

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial Active, not recruiting
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE Recruiting
Evolut™ EXPAND TAVR II Pivotal Trial Active, not recruiting
TTVR Early Feasibility Study Active, not recruiting
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07321899 on ClinicalTrials.gov ↗ ← All trials in the USA