The TRICURE EFS Study

NCT06506942 · tracked via the Priya Life Science Canada tracker

Sponsor

TRiCares

Phase

Not applicable

Started

2024-09-11

Last updated

2026-07-23

Condition(s) studied

Tricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular Diseases

Investigational drug(s) / intervention(s)

Transcatheter Tricuspid Valve Replacement

Transcatheter Tricuspid Valve Replacement: Replacement of the tricuspid valve through a transcatheter approach

Study summary

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Adult patients * Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential) * Institutional Heart Team evaluates patient as being at increased operative risk Exclusion Criteria: * Patient in need of emergent intervention * Patient who is hemodynamically unstable * Anatomical contraindications for implantation with study device * Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

Primary outcome measure(s)

Composite of MAE — 30 day post-intervention
Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
Device Success — immediately post-intervention
Device success defined as a reduction in tricuspid regurgitation immediately post-intervention

Trial sites (10)

Facility	City	Region	Status
Piedmont Healthcare Inc.	Atlanta	Georgia	Recruiting
Northwestern	Chicago	Illinois	Recruiting
University of Michigan Hospital and Health Systems	Ann Arbor	Michigan	Recruiting
Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	Recruiting
Columbia University Medical Center/ NewYork Presbyterian Hospital	New York	New York	Recruiting
Montefiore	The Bronx	New York	Recruiting
The Christ Hospital	Cincinnati	Ohio	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
St. Paul's Hospital	Vancouver	British Columbia	Recruiting
St. Michaels Hospital	Toronto	Ontario	Recruiting

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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 NCT06506942 on ClinicalTrials.gov ↗ ← All trials in Canada