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Clinical Trials/NCT05126030
NCT05126030
Active, not recruiting
Not Applicable

TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First in Human Trial

TRiCares11 sites in 2 countries20 target enrollmentJuly 15, 2022
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ConditionsTricuspid Regurgitation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tricuspid Regurgitation
Sponsor
TRiCares
Enrollment
20
Locations
11
Primary Endpoint
Hierarchical composite endpoint
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

Detailed Description

The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
May 15, 2029
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
TRiCares
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Subject of age \>18 years.
  • •Subject with severe symptomatic tricuspid regurgitation presenting following conditions:
  • •TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or
  • •symptoms requiring use of diuretics.
  • •Subject presenting with New York Heart Association Class NYHA ≥II.
  • •Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.

Exclusion Criteria

  • •Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months.
  • •Subject undergoing cardiac interventions within 30 days prior to index procedure.
  • •Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis.
  • •Subject who had previous tricuspid valve replacement or repair and a device is still in situ.

Outcomes

Primary Outcomes

Hierarchical composite endpoint

Time Frame: 30 days

including all-cause mortality, re-hospitalization for heart failure, re-intervention for failed tricuspid intervention, and KCCQ worsening at 30 days

Study Sites (11)

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