Safety and Performance of the Cardiovalve TR Replacement System

Last updated: February 6, 2024
Sponsor: Cardiovalve Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Treatment

Cardiovalve TR valve replacement System

Clinical Study ID

NCT05486832
CP-21-01
  • Ages 18-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Cardiovalve TR valve replacement System
Phase:
Study Start date:
December 09, 2022
Estimated Completion Date:
December 15, 2026

Study 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

Connect with a study center

  • Universität Bochum

    Bad Oeynhausen, 32545
    Germany

    Active - Recruiting

  • Charité university

    Berlin, 10117
    Germany

    Active - Recruiting

  • Uniklinik Bonn

    Bonn, 53127
    Germany

    Active - Recruiting

  • Universitäres Herz

    Hamburg, 20251
    Germany

    Active - Recruiting

  • Herzzentrum Uniklinik

    Köln, 50937
    Germany

    Active - Recruiting

  • University Heart Center Lübeck

    Lübeck, 20251
    Germany

    Active - Recruiting

  • Universitätsklinikum - Regensburg

    Regensburg, 93053
    Germany

    Active - Recruiting

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