NCT07528326

Brief Summary

The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
831

participants targeted

Target at P75+ for not_applicable

Timeline
109mo left

Started Oct 2026

Longer than P75 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2035

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

April 7, 2026

Last Update Submit

April 29, 2026

Conditions

Tricuspid Regurgitation (TR)

Outcome Measures

Primary Outcomes (2)

  • Rate of Major Adverse Events (MAE)

    30 days post-procedure

  • Composite Endpoint

    All-cause mortality, heart failure hospitalization, non-elective tricuspid valve reintervention

    1 year post-procedure

Secondary Outcomes (1)

  • Change in qualify of life (QoL)

    1 year post-procedure

Study Arms (3)

TRiCares Topaz TTVR

EXPERIMENTAL

Transcatheter tricuspid valve replacement with TRiCares Topaz TTVR

Device: TRiCares Topaz TTVR System

Edwards EVOQUE TTVR

ACTIVE COMPARATOR

Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR

Device: Edwards EVOQUE TTVR System

Single Arm Registry

EXPERIMENTAL

Patients eligible to receive the TRiCares Topaz TTVR system, but not eligible for the Edwards EVOQUE system will be enrolled in the non-randomized, single-arm registry and treated with Topaz TTVR.

Device: TRiCares Topaz TTVR System

Interventions

TRiCares Topaz TTVR SystemDEVICE

TRiCares Topaz TTVR System

TRiCares Topaz TTVR
Edwards EVOQUE TTVR SystemDEVICE

Edwards EVOQUE TTVR System

Edwards EVOQUE TTVR

Eligibility Criteria

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

You may qualify if:

  • Patient is ≥ 18 years of age
  • Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy
  • Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team

You may not qualify if:

  • Patient has a tricuspid device currently in place
  • Patient has anatomical contraindications
  • Patient is in need of urgent surgery
  • Patient has a left ventricular ejection fraction of \< 25%
  • Patient has life expectancy of \< 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Pradeep Yadav, MD

    Piedmont Hospital

    PRINCIPAL INVESTIGATOR

  • Neil Fam, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Cihlar

CONTACT

763-227-7833cihlar@tricares.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2035

Last Updated

May 5, 2026

Record last verified: 2026-04