Recruiting

TRICUREThe TRICURE EFS Study

Sponsor:

TRiCares

Code:

NCT06506942

Conditions

Tricuspid Valve Regurgitation

Heart Valve Diseases

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcatheter Tricuspid Valve Replacement

Study Details

Brief summary:

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

Conditions

Tricuspid Valve Regurgitation

Heart Valve Diseases

Cardiovascular Diseases

Study ID

NCT06506942

Start date

Sep 11, 2024

Status verified date

Jul, 2026

Completion date

Mar, 2031

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcatheter Tricuspid Valve Replacement

Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

Interventions

Transcatheter Tricuspid Valve Replacement

Replacement of the tricuspid valve through a transcatheter approach

Primary outcome measure

Composite of MAE [ Time Frame: 30 day post-intervention ]
Device Success [ Time Frame: immediately post-intervention ]

Central Contacts and Locations

Central contacts

Esther Gerteis

+41796015318 gerteis@tricares.de

Locations

Piedmont Healthcare Inc.

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Pradeep Yadav, MD

404-605-6517 pradeep.yadav@piedmont.org

Principal Investigator:

Pradeep Yadav, MD

Northwestern

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Anita Asgar, MD

312-664-3278 anita.asgar@northwestern.edu

Principal Investigator:

Anita Asgar, MD

University of Michigan Hospital and Health Systems

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Gorav Ailawadi, MD

734-936-4974 ailawadi@umich.edu

Principal Investigator:

Gorav Ailawadi, MD

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Vinayak Bapat, MD

612-863-6900 vinayak.bapat@allina.com

Jason Digman

jason.digman@allina.com

Principal Investigator:

Vinayak Bapat, MD

Columbia University Medical Center/ NewYork Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Susheel Kodali, MD

212-342-0444 sk2427@cumc.columbia.edu

Principal Investigator:

Susheel Kodali, MD

Montefiore

Recruiting

The Bronx, New York, United States, 10461

Contacts

Azeem Latib, MD

718-920-4212 mlatib@montefiore.org

Principal Investigator:

Azeem Latib, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Santiago Garcia, MD

513-206-1222 santiago.garcia@thechristhospital.com

Principal Investigator:

Santiago Garcia, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Nicholas S. Amoroso, MD

8438760940 amoroson@musc.edu

Principal Investigator:

Nicholas S. Amoroso, MD

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z1Y6

Contacts

Robert Boone, MD

604-806-8804 robert.boone@phc.ca

St. Michaels Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Neil Fam, MD

4168645939 neil.fam@unityhealth.to

Principal Investigator:

Neil Fam, MD

More Information

Sponsor

TRiCares

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TRiCares on 2026-07-23.