Berlin Registry of Right Heart Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband).
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation, Pulmonary Regurgitation. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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).
Primary outcome measures
- Overall mortality [Time frame: 2 months after intervention]
- Cardiovascular mortality [Time frame: 2 months after intervention]
- Unscheduled hospitalization for heart failure progression [Time frame: 2 months after intervention]
Secondary outcome measures (7)
- NYHA class [Time frame: 2 months after intervention]
- NTproBNP [Time frame: 2 months after intervention]
- valve function [Time frame: 2 months after intervention]
- liver function [Time frame: 2 months after intervention]
- kidney function [Time frame: 2 months after intervention]
- cardiac function [Time frame: 2 months after intervention]
- cardiac morphology [Time frame: 2 months after intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Charité - Universitätsmedizin Berlin — Berlin
Identifiers
NCT: NCT04570163 · EA1/043/20