NCT06506942

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
60mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
2 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Sep 2024Mar 2031

First Submitted

Initial submission to the registry

July 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 11, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

July 11, 2024

Last Update Submit

April 10, 2026

Conditions

Tricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Six minute walk test

    30 days, 6 months, annual for five years post-intervention

  • Reduction in Tricuspid Regurgitation (TR) Grade

    30 days, 6 months, annual for five years post-intervention

  • New York Heart Association (NYHA) Function Class

    30 days, 6 months, annual for five years post-intervention

Study Arms (1)

Transcatheter Tricuspid Valve Replacement

EXPERIMENTAL

Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

Device: Transcatheter Tricuspid Valve Replacement

Interventions

Transcatheter Tricuspid Valve ReplacementDEVICE

Replacement of the tricuspid valve through a transcatheter approach

Also known as: TRiCares Topaz Tricuspid Valve Replacement System
Transcatheter Tricuspid Valve Replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Piedmont Healthcare Inc.

Atlanta, Georgia, 30309, United States

RECRUITING

Northwestern

Chicago, Illinois, 60611, United States

RECRUITING

University of Michigan Hospital and Health Systems

Ann Arbor, Michigan, 48109, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Columbia University Medical Center/ NewYork Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Montefiore

The Bronx, New York, 10461, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

St. Michaels Hospital

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyHeart Valve DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

  • Susheel Kodali, MD

    Columbia University Medical Center/ NewYork Presbyterian Hospital

    PRINCIPAL INVESTIGATOR

  • Gorav Ailawadi, MD

    University of Michigan Hospital and Health Systems

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Gerteis

CONTACT

+41796015318gerteis@tricares.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 18, 2024

Study Start

September 11, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2031

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(8)