Safety and Performance of the Cardiovalve TR Replacement System

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Description

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

Targeted Conditions

Study Overview

Start Date
December 9, 2022
Completion Date
December 15, 2026
Enrollment
100
Date Posted
August 4, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Universität Bochum
Bad Oeynhausen 32545, Germany

Charité university
Berlin 10117, Germany

Uniklinik Bonn
Bonn 53127, Germany

Universitäres Herz
Hamburg 20251, Germany

Herzzentrum Uniklinik
Köln 50937, Germany

University Heart Center Lübeck
Lübeck 20251, Germany

Universitätsklinikum - Regensburg
Regensburg 93053, Germany

Eligibility

Minimum Age (years)
18
Maximum Age (years)
85
Eligibility Criteria
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 Contact Info

Study Contact Name
Nitza Shoham, PhD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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
NCTid (if applicable)
NCT05486832