Berlin Registry of Right Heart Interventions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Berlin Registry of Right Heart Interventions

Conditions
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Tricuspid Regurgitation, Pulmonary Regurgitation

Intervention / Treatment
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* Device: Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | Number of deceased participants after 2 months after intervention | 2 months after intervention | 
| Cardiovascular mortality | Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality) | 2 months after intervention | 
| Unscheduled hospitalization for heart failure progression | Number of participants with unscheduled hospitalization for heart failure progression after 2 months after intervention | 2 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA class | New York Heart Association (NYHA) class (to rate dyspnea in heart failure patients) | 2 months after intervention | 
| NTproBNP | Laboratory measurement of NTproBNP 2 months after intervention | 2 months after intervention | 
| valve function | Echocardiographic quantification of valve function (proximal isovelocity surface area [PISA] method, effective regurgitant orifice [ERO], vena contracta [VC]) after 2 months after intervention | 2 months after intervention | 
| liver function | Laboratory measurement of bilirubin 2 months after intervention | 2 months after intervention | 
| kidney function | Laboratory measurement of creatinine 2 months after intervention | 2 months after intervention | 
| cardiac function | Echocardiographic measurement of cardiac function (left ventricular ejection fraction, tricuspid anular plane systolic excursion) after 2 months after intervention | 2 months after intervention | 
| cardiac morphology | Echocardiographic measurement of cardiac morphology (right ventricular and right atrial diameter) after 2 months after intervention | 2 months after intervention |