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NCT Number: NCT04570163

Berlin Registry of Right Heart Interventions

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.

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pulmonary Regurgitation Pulmonary Valve Insufficiency Tricuspid Valve Insufficiency

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)

Device

Catheter-based therapy of valve diseases of the right heart with various devices (e. g. TriClip, Cardioband).

Primary outcomes

  1. Overall mortality

    Time frame: 2 months after intervention

    Number of deceased participants after 2 months after intervention

  2. Cardiovascular mortality

    Time frame: 2 months after intervention

    Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality)

  3. Unscheduled hospitalization for heart failure progression

    Time frame: 2 months after intervention

    Number of participants with unscheduled hospitalization for heart failure progression after 2 months after intervention

Secondary outcomes

  1. NYHA class

    Time frame: 2 months after intervention

    New York Heart Association (NYHA) class (to rate dyspnea in heart failure patients)

  2. NTproBNP

    Time frame: 2 months after intervention

    Laboratory measurement of NTproBNP 2 months after intervention

  3. valve function

    Time frame: 2 months after intervention

    Echocardiographic quantification of valve function (proximal isovelocity surface area [PISA] method, effective regurgitant orifice [ERO], vena contracta [VC]) after 2 months after intervention

  4. liver function

    Time frame: 2 months after intervention

    Laboratory measurement of bilirubin 2 months after intervention

  5. kidney function

    Time frame: 2 months after intervention

    Laboratory measurement of creatinine 2 months after intervention

  6. cardiac function

    Time frame: 2 months after intervention

    Echocardiographic measurement of cardiac function (left ventricular ejection fraction, tricuspid anular plane systolic excursion) after 2 months after intervention

  7. cardiac morphology

    Time frame: 2 months after intervention

    Echocardiographic measurement of cardiac morphology (right ventricular and right atrial diameter) after 2 months after intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Henryk Dreger, Prof. Dr. med.

CONTACT

[email protected]

+4930450613496

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2020
Primary completion
2035
Study completion
2035
First posted
Sep 30, 2020
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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