The TRICURE EFS Study (TRICURE EFS)

The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Regurgitation
• Intervention / Treatment: Device: Transcatheter Tricuspid Valve Replacement

Detailed Description

The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esther Gerteis; Phone Number: +41796015318; Email: gerteis@tricares.de

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • St. Michaels Hospital
      • Principal Investigator: Neil Fam, MD
      • Contact: Neil Fam, MD; Phone Number: 4168645939; Email: neil.fam@unityhealth.to
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont Healthcare Inc.
      • Principal Investigator: Pradeep Yadav, MD
      • Contact: Pradeep Yadav, MD; Phone Number: 404-605-6517; Email: pradeep.yadav@piedmont.org
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern
      • Principal Investigator: Anita Asgar, MD
      • Contact: Anita Asgar, MD; Phone Number: 312-664-3278; Email: anita.asgar@northwestern.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Hospital and Health Systems
      • Principal Investigator: Gorav Ailawadi, MD
      • Contact: Gorav Ailawadi, MD; Phone Number: 734-936-4974; Email: ailawadi@umich.edu
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute Foundation
      • Principal Investigator: Vinayak Bapat, MD
      • Contact: Vinayak Bapat, MD; Phone Number: 612-863-6900; Email: vinayak.bapat@allina.com
      • Contact: Jason Digman; Email: jason.digman@allina.com
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center/ NewYork Presbyterian Hospital
      • Principal Investigator: Susheel Kodali, MD
      • Contact: Susheel Kodali, MD; Phone Number: 212-342-0444; Email: sk2427@cumc.columbia.edu
    • The Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore
      • Principal Investigator: Azeem Latib, MD
      • Contact: Azeem Latib, MD; Phone Number: 718-920-4212; Email: mlatib@montefiore.org
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital
      • Principal Investigator: Santiago Garcia, MD
      • Contact: Santiago Garcia, MD; Phone Number: 513-206-1222; Email: santiago.garcia@thechristhospital.com
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Nicholas S. Amoroso, MD; Phone Number: 843-876-0940; Email: amoroson@musc.edu
      • Principal Investigator: Nicholas S. Amoroso, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter Tricuspid Valve Replacement; Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System	Device: Transcatheter Tricuspid Valve Replacement; Replacement of the tricuspid valve through a transcatheter approach; Other Names: TRiCares Topaz Tricuspid Valve Replacement System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six minute walk test	Change in distance (m) compared to baseline assessment	30 days, 6 months, annual for five years post-intervention
Reduction in Tricuspid Regurgitation (TR) Grade	Number of patients presenting with reduction in TR grade compared to baseline assessment	30 days, 6 months, annual for five years post-intervention
New York Heart Association (NYHA) Function Class	Number of patients presenting with improvement in NYHA classification	30 days, 6 months, annual for five years post-intervention

Collaborators and Investigators

• Sponsor: TRiCares
• Investigators: Principal Investigator: Susheel Kodali, MD, Columbia University Medical Center/ NewYork Presbyterian Hospital; Principal Investigator: Gorav Ailawadi, MD, University of Michigan Hospital and Health Systems

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Tricuspid Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: 2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No