Berlin Registry of Right Heart Interventions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorCharite University, Berlin, Germany
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation/ stenosis, pulmonary regurgitation/ stenosis)
>18 years
Written, documented consent
Disqualifiers
Patients in care or unable to consent
Patients who are unable to comply with follow-up examinations
Patients who are detained in an institution
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)
DeviceCatheter-based therapy of valve diseases of the right heart with various devices (e. g. TriClip, Cardioband).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Overall mortality
Number of deceased participants after 2 months after intervention
Time frame
2 months after intervention2
Cardiovascular mortality
Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality)
Time frame
2 months after intervention3
Unscheduled hospitalization for heart failure progression
Number of participants with unscheduled hospitalization for heart failure progression after 2 months after intervention
Time frame
2 months after interventionSecondary outcomes
1
NYHA class
New York Heart Association (NYHA) class (to rate dyspnea in heart failure patients)
Time frame
2 months after intervention2
NTproBNP
Laboratory measurement of NTproBNP 2 months after intervention
Time frame
2 months after intervention3
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
Time frame
2 months after intervention4
liver function
Laboratory measurement of bilirubin 2 months after intervention
Time frame
2 months after interventionSponsors and contacts
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Source ClinicalTrials.gov