About this trial
Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair
Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.
Disqualifiers
No agreement to participation
Age < 18 years
Trial population
Patients with severe symptomatic tricuspid regurgitation, who are not eligible for cardiac surgery due to a high risk of mortality.
Trial design
Cohort
Prospective
Treatments tested in this trial
Interventional treatment of tricuspid regurgitation
DeviceInterventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair
Treatment groups
Trial outcomes
Primary outcomes
All-cause death and heart failure hospitalisation
All-cause death and heart failure hospitalisation 1 year after transcatheter tricuspid valve treatment (TTVT)
Secondary outcomes
All-cause death and heart failure hospitalisation (long-term)
Long-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)
All-cause death and heart failure hospitalisation (short-term)
Short-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)
Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT)
Assessed by echocardiography, tricuspid regurgitation graded on a 4-grade scale.
Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)
Assessment for cardiopulmonal symptoms include edema scaling
Other outcomes
Safety outcome after transcatheter tricuspid valve treatment (TTVT)
The saftety outcome contains all complications which occur between the interventional treatment of the tricuspid regurgitation and discharge from the hospital. Data collection includes: mortality with differentiation of cardiac death and non-cardiac death, unplanned cardiac surgery, re-intervention of tricuspid valve, pericardial tamponade, intervention of coronary arteries. Moreover major adverse events as defined by MVARC2 criteria are recorded at discharge from hospital: death with differentiation of cardiac death and non-cardiac death, peri-procedural or spontaneous myocardial infarction, stroke, transient ischemic attack, life-threatening, major or minor bleeding, acute kidney failure, complications of the vascular access.
Sponsors and contacts
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LMU Klinikum
Lead sponsor
Heart and Diabetes Center North Rhine-Westphalia
Collaborator
Heart Center Leipzig - University Hospital
Collaborator
Mainz University
Collaborator
Universitätsklinikum Köln
Collaborator
University Hospital, Essen
Collaborator