German Registry for Transcatheter Tricuspid Valve Interventions

LMU Klinikum

Status: Enrolling

Conditions: Tricuspid Valve Insufficiency; Heart Valve; Tricuspid Regurgitation

Treatments: Device: Interventional treatment of tricuspid regurgitation

Study type: Observational

Funder types: Other

Identifiers

NCT04653428

D-TRIK

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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