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TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First In Human Trial (TRICURE)

Primary Purpose

Tricuspid Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Topaz TTVR System
Sponsored by
TRiCares GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject of age >18 years.

  • Subject with severe symptomatic tricuspid regurgitation presenting following conditions:

    1. TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or
    2. 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.

Sites / Locations

  • Algemeen Stedelijk Ziekenhuis,Recruiting
  • ZNA MiddelheimRecruiting
  • Cliniques Universitaires Saint-Luc UCLRecruiting
  • Centre hospitalier universitaire CHU de LiègeRecruiting
  • CHU Bordeaux
  • Hospices Civils de Lyon, Hôpital Cardiothoracique Louis Pradel
  • CHU Henri Mondor
  • University Hospital Lille, Institut Cœur Poumon
  • Hôpital Saint Joseph
  • CHU Pontchaillou
  • Centre Cardiologique du Nord

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary Cohort

Arm Description

Device: Topaz TTVR system

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 28, 2021
Last Updated
May 2, 2023
Sponsor
TRiCares GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05126030
Brief Title
TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First In Human Trial
Acronym
TRICURE
Official Title
TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First In Human Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
March 15, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TRiCares GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Topaz TTVR System
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary Cohort
Arm Type
Experimental
Arm Description
Device: Topaz TTVR system
Intervention Type
Device
Intervention Name(s)
Topaz TTVR System
Intervention Description
Transcatheter tricuspid heart valve replacement
Primary Outcome Measure Information:
Title
Hierarchical composite endpoint
Description
including all-cause mortality, re-hospitalization for heart failure, re-intervention for failed tricuspid intervention, and KCCQ worsening at 30 days
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Gerteis
Phone
+41796015318
Email
gerteis@tricares.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Vanoverschelde, MD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel Teiger, MD
Organizational Affiliation
CHU Henri Mondor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algemeen Stedelijk Ziekenhuis,
City
Aalst
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liesbeth Rosseel, MD
Facility Name
ZNA Middelheim
City
Antwerpen
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Verheye, MD
Facility Name
Cliniques Universitaires Saint-Luc UCL
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Vanoverschelde, MD
Facility Name
Centre hospitalier universitaire CHU de Liège
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizio Lancellotti, MD
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Modine, MD
First Name & Middle Initial & Last Name & Degree
Julien Ternacle, MD
Facility Name
Hospices Civils de Lyon, Hôpital Cardiothoracique Louis Pradel
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François Obadia, MD
Facility Name
CHU Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Teiger, MD
First Name & Middle Initial & Last Name & Degree
Romain Gallet, MD
Facility Name
University Hospital Lille, Institut Cœur Poumon
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric van Belle, MD
Facility Name
Hôpital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leopold Oliver, MD
First Name & Middle Initial & Last Name & Degree
Alexandre Metras, MD
Facility Name
CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erwan Donal, MD
First Name & Middle Initial & Last Name & Degree
Guillaume Leurent, MD
Facility Name
Centre Cardiologique du Nord
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Dreyfus, MD
First Name & Middle Initial & Last Name & Degree
Mohammed Nejjari, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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