Berlin Registry of Right Heart Interventions

Charité University Medicine Berlin

Status: Enrolling

Conditions: Pulmonary Regurgitation; Tricuspid Regurgitation

Treatments: Device: Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)

Study type: Observational

Funder types: Other

Identifiers

NCT04570163

EA1/043/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation/ stenosis, pulmonary regurgitation/ stenosis)
• >18 years
• Written, documented consent

Exclusion criteria

• Patients in care or unable to consent
• Patients who are unable to comply with follow-up examinations
• Patients who are detained in an institution