NCT04653428

German Registry for Transcatheter Tricuspid Valve Interventions

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency
• Heart Valve

Interventions

Type	Name	Description
DEVICE	Interventional treatment of tricuspid regurgitation	Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair

Timeline

• Start date: 2020-10-01
• Primary completion: 2025-12-31
• Completion: 2030-12-31
• First posted: 2020-12-04
• Last updated: 2020-12-04

Locations

1 site across 1 country: Germany