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

N/AActive Not RecruitingNCT05486832

Cardiovalve Ltd.157 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

157

Conditions

Tricuspid Regurgitation

Interventions

Cardiovalve TR valve replacement SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (7)

Universität Bochum

Bad Oeynhausen, Germany

Charité university

Berlin, Germany

Uniklinik Bonn

Bonn, Germany

Herzzentrum Uniklinik

Cologne, Germany

Outcomes

Primary Outcomes

Freedom from device or procedure-related adverse events

Time frame: 30 days

Reduction in TR grade

Reduction in TR in comparison to baseline

Time frame: 30 days

Secondary Outcomes

Six minute walk test

Change in Six minute walk distance from Baseline

Time frame: 30 days, 6 months, 12 months, annual for five years

KCCQ

Change in health status from Baseline

Time frame: 30 days, 6 months, 12 months, annual for five years

Data from ClinicalTrials.gov

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