Safety and Performance of the Cardiovalve TR Replacement System

Not Applicable

Recruiting

• Conditions: Tricuspid Regurgitation

• Registration Number: NCT05486832
• Lead Sponsor: Cardiovalve Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Study Start: 2022-12-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2026-08-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Freedom from device or procedure-related adverse events	30 days	Freedom from device or procedure-related adverse events
Reduction in TR grade	30 days	Reduction in TR in comparison to baseline

Secondary Outcome Measures

Name	Time	Method
Six minute walk test	30 days, 6 months, 12 months, annual for five years	Change in Six minute walk distance from Baseline
KCCQ	30 days, 6 months, 12 months, annual for five years	Change in health status from Baseline

Trial Locations

Locations (7)

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, Germany