Berlin Registry of Right Heart Interventions

NCT04570163 | Recruiting FDA Device

• 1 other identifier: EA1/043/20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tricuspid Regurgitation; Pulmonary Regurgitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• NYHA class

  2 months after intervention

• NTproBNP

  2 months after intervention

• valve function

  2 months after intervention

• liver function

  2 months after intervention

• kidney function

  2 months after intervention

Interventions

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).

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after interventional therapy of valvular diseases of the right heart (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Pulmonary Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Henryk Dreger, Prof. Dr. med.

CONTACT

+4930450613496; henryk.dreger@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 30, 2020
• Study Start: June 16, 2020
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)