Berlin Registry of Right Heart Interventions

Tricuspid Regurgitation Clinical Trial

Official title:

Berlin Registry of Right Heart Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04570163
• Other study ID #: EA1/043/20
• Status: Recruiting
• Start date: June 16, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Henryk Dreger, Prof. Dr. med.
• Phone: +4930450613496
• Email: henryk.dreger[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Regurgitation
• Pulmonary Valve Insufficiency
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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).

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality	Number of deceased participants after 2 months after intervention	2 months after intervention
Primary	Cardiovascular mortality	Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality)	2 months after intervention
Primary	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	NYHA class	New York Heart Association (NYHA) class (to rate dyspnea in heart failure patients)	2 months after intervention
Secondary	NTproBNP	Laboratory measurement of NTproBNP 2 months after intervention	2 months after intervention
Secondary	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
Secondary	liver function	Laboratory measurement of bilirubin 2 months after intervention	2 months after intervention
Secondary	kidney function	Laboratory measurement of creatinine 2 months after intervention	2 months after intervention
Secondary	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
Secondary	cardiac morphology	Echocardiographic measurement of cardiac morphology (right ventricular and right atrial diameter) after 2 months after intervention	2 months after intervention