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OpenTrials
Active, Not Recruiting

NCT Number: NCT05486832

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universität Bochum, Bad Oeynhausen, Germany

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiovalve TR valve replacement System

Device

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

Primary outcomes

  1. Freedom from device or procedure-related adverse events

    Time frame: 30 days

    Freedom from device or procedure-related adverse events

  2. Reduction in TR grade

    Time frame: 30 days

    Reduction in TR in comparison to baseline

Secondary outcomes

  1. Six minute walk test

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

    Change in Six minute walk distance from Baseline

  2. KCCQ

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

    Change in health status from Baseline

Sponsors and collaborators

Lead sponsor

Cardiovalve Ltd.

Industry

Registry information

Official study title

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

Acronym: TARGET

Important dates

Study start
2022
Primary completion
2026
Study completion
2031
First posted
Aug 4, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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