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German Registry for Transcatheter Tricuspid Valve Interventions

Recruiting
18 years of age
Both
Phase N/A

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Overview

Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.

Description

Severe tricuspid regurgitation occurs in around 1.5 % of men and 5.6 % of women and it is associated with significant morbidity and mortality. Current guidelines recommend cardiac surgery, especially in those patients who are undergoing left side valve surgery. Nevertheless many patients are not eligible for surgical tricuspid valve repair due to an high risk of mortality. Therefore interventional devices for treatment of tricuspid regurgitation have been established to offer these patients an alternative treatment option. The aim of this study is to analyse the success and saftey aspects of different interventional repair techniques for severe tricuspid regurgitation. Therefore in this prospectively designed observational study clinical, echocardiographic and laboratory parameters will be collected.

Eligibility

Inclusion Criteria:

  • Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair
  • Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.

Exclusion Criteria:

  • No agreement to participation
  • Age < 18 years

Study details

Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve

NCT04653428

LMU Klinikum

25 January 2024

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