Pulmonary Regurgitation, Tricuspid Regurgitation
Conditions
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.
Detailed 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.
Interventions
DEVICEInterventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)
Catheter-based therapy of valve diseases of the right heart with various devices (e. g. TriClip, Cardioband).
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall mortality | 2 months after intervention | Number of deceased participants after 2 months after intervention |
| Cardiovascular mortality | 2 months after intervention | Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality) |
| Unscheduled hospitalization for heart failure progression | 2 months after intervention | Number of participants with unscheduled hospitalization for heart failure progression after 2 months after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| liver function | 2 months after intervention | Laboratory measurement of bilirubin 2 months after intervention |
| kidney function | 2 months after intervention | Laboratory measurement of creatinine 2 months after intervention |
| cardiac function | 2 months after intervention | Echocardiographic measurement of cardiac function (left ventricular ejection fraction, tricuspid anular plane systolic excursion) after 2 months after intervention |
| NTproBNP | 2 months after intervention | Laboratory measurement of NTproBNP 2 months after intervention |
| cardiac morphology | 2 months after intervention | Echocardiographic measurement of cardiac morphology (right ventricular and right atrial diameter) after 2 months after intervention |
| NYHA class | 2 months after intervention | New York Heart Association (NYHA) class (to rate dyspnea in heart failure patients) |
| valve function | 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 |
Countries
Germany
Contacts
CONTACTHenryk Dreger, Prof. Dr. med.
Outcome results
None listed