NCT04570163

Berlin Registry of Right Heart Interventions

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: —

Summary

The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.

Detailed description

The subject of the study is to register interventional therapies of right heart diseases (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin). Based on the development and the increasing use of interventional therapies in tricuspid and pulmonary valve diseases, the impact on the patients' symptoms and life expectancy after interventions will be investigated. The aim is to identify patient subgroups that benefit the most. Primary endpoints: Total mortality, cardiovascular mortality, heart failure hospitalization. Secondary endpoints: NYHA class, NTproBNP, liver and kidney function (laboratory measurements), valve function, cardiac function, and cardiac morphology.

Conditions

• Tricuspid Regurgitation
• Pulmonary Regurgitation

Interventions

Type	Name	Description
DEVICE	Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)	Catheter-based therapy of valve diseases of the right heart with various devices (e. g. TriClip, Cardioband).

Timeline

• Start date: 2020-06-16
• Primary completion: 2035-12-31
• Completion: 2035-12-31
• First posted: 2020-09-30
• Last updated: 2026-03-19

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study