"TARGET Study": Safety and Performance of the Cardiovalve TR Replacement System

NCT ID: NCT05486832

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-09

Study Completion Date

2033-12-15

Brief Summary

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

Detailed Description

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

Conditions

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Tricuspid Regurgitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, single arm, open label, multi center
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cardiovalve TR replacement Group

Cardiovalve TR valve replacement System

Group Type EXPERIMENTAL

Cardiovalve TR valve replacement System

Intervention Type DEVICE

The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.

Interventions

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Cardiovalve TR valve replacement System

The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiovalve Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georg Nickenig, Dr

Role: PRINCIPAL_INVESTIGATOR

Bonn Clinic

Locations

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Universität Bochum

Bad Oeynhausen, , Germany

Site Status RECRUITING

Charité university

Berlin, , Germany

Site Status RECRUITING

Uniklinik Bonn

Bonn, , Germany

Site Status RECRUITING

Herzzentrum Uniklinik

Cologne, , Germany

Site Status RECRUITING

Universitäres Herz

Hamburg, , Germany

Site Status RECRUITING

University Heart Center Lübeck

Lübeck, , Germany

Site Status RECRUITING

Universitätsklinikum - Regensburg

Regensburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Dana Raveh Arbel

Role: CONTACT

+972528591891

Facility Contacts

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Rudolph Volker, MD

Role: primary

Sherif Mohammad, MD

Role: primary

Georg Nickenig, MD

Role: primary

Adam Matti, MD

Role: primary

Niklas Schofer, MD

Role: primary

Christian. Frerker, MD

Role: primary

Michael Hilker, MD

Role: primary

Other Identifiers

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CP-21-01

Identifier Type: -

Identifier Source: org_study_id

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