About this trial
Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Successful treatment with TricValve Transcatheter Bicaval Valves System
Patient/patient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent
Disqualifiers
no exclusion criterion
Trial population
The study shall enrol subjects who were treated with the TricValve® Transcatheter Bicaval Valves System® in the Inferior Vena Cava and Superior vena cava. On compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study.
Trial design
Case-only
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of patients with readmission for HF
First unplanned readmission for Heart Failure
Secondary outcomes
All cause mortality
Number of patients in terms of all cause mortality
Percentage of participants with major adverse events
Percentage of participants with major adverse events
Number of participants with severe adverse events
Number of participants with severe adverse events
Number of patients with readmission for HF
First unplanned readmission for Heart Failure
Sponsors and contacts
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