Safety and Performance of the Cardiovalve TR Replacement System (TARGET)

February 6, 2024 updated by: Cardiovalve Ltd.

Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation

The objective of this study is to evaluate the safety and performance of Cardiovalve TR system

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Universität Bochum
        • Contact:
          • Rudolph Volker, MD
      • Berlin, Germany, 10117
        • Recruiting
        • Charité University
        • Contact:
          • Sherif Mohammad, MD
      • Bonn, Germany, 53127
        • Recruiting
        • Uniklinik Bonn
        • Contact:
          • Georg Nickenig, MD
      • Hamburg, Germany, 20251
        • Recruiting
        • Universitäres Herz
        • Contact:
          • Niklas Schofer, MD
      • Köln, Germany, 50937
        • Recruiting
        • Herzzentrum Uniklinik
        • Contact:
          • Adam Matti, MD
      • Lübeck, Germany, 20251
        • Recruiting
        • University Heart Center Lübeck
        • Contact:
          • Christian. Frerker, MD
      • Regensburg, Germany, 93053
        • Recruiting
        • Universitätsklinikum - Regensburg
        • Contact:
          • Michael Hilker, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Functional TR ≥3+
  • Symptomatic, NYHA Class II-IVa
  • Patient approved by the Subject Screening Committee

Exclusion Criteria:

  • Cardiac anatomy deemed not suitable for the Cardiovalve TR system
  • Hemodynamic instability
  • Severe right ventricular failure
  • Refractory heart failure requiring advanced intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiovalve TR replacement Group
Cardiovalve TR valve replacement System
Device: Cardiovalve TR valve replacement System
The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from device or procedure-related adverse events
Time Frame: 30 days
Freedom from device or procedure-related adverse events
30 days
Reduction in TR grade
Time Frame: 30 days
Reduction in TR in comparison to baseline
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six minute walk test
Time Frame: 30 days, 6 months, 12 months, annual for five years
Change in Six minute walk distance from Baseline
30 days, 6 months, 12 months, annual for five years
KCCQ
Time Frame: 30 days, 6 months, 12 months, annual for five years
Change in health status from Baseline
30 days, 6 months, 12 months, annual for five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiovalve Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2022

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-21-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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