Berlin Registry of Right Heart Interventions

NCT ID: NCT04570163

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-16

Study Completion Date

2025-12-31

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.

Conditions

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Tricuspid Regurgitation Pulmonary Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Henryk Dreger

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Henryk Dreger, Prof. Dr. med.

Role: CONTACT

+4930450613496

Facility Contacts

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Henryk Dreger, Prof. Dr. med.

Role: primary

+49 (0) 30 450 61 34 96

Other Identifiers

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EA1/043/20

Identifier Type: -

Identifier Source: org_study_id

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