Safety and Performance of the Cardiovalve TR Replacement System

Tricuspid Regurgitation Clinical Trial

— TARGET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05486832
• Other study ID #: CP-21-01
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2022
• Est. completion date: December 15, 2026

Study information

• Verified date: February 2024
• Source: Cardiovalve Ltd.
• Contact: Nitza Shoham, PhD
• Phone: +972546882988
• Email: nitza[@]cardiovalve.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2026
• Est. primary completion date: August 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Germany	Universität Bochum	Bad Oeynhausen
Germany	Charité university	Berlin
Germany	Uniklinik Bonn	Bonn
Germany	Universitäres Herz	Hamburg
Germany	Herzzentrum Uniklinik	Köln
Germany	University Heart Center Lübeck	Lübeck
Germany	Universitätsklinikum - Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovalve Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device or procedure-related adverse events	Freedom from device or procedure-related adverse events	30 days
Primary	Reduction in TR grade	Reduction in TR in comparison to baseline	30 days
Secondary	Six minute walk test	Change in Six minute walk distance from Baseline	30 days, 6 months, 12 months, annual for five years
Secondary	KCCQ	Change in health status from Baseline	30 days, 6 months, 12 months, annual for five years