Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorP+F Products + Features GmbH

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Number of patients with readmission for HF

First unplanned readmission for Heart Failure

Time frame
up to 12 months

Secondary outcomes

1

All cause mortality

Number of patients in terms of all cause mortality

Time frame
up to 30 days, up to 6 months, up to 5 years
2

Percentage of participants with major adverse events

Percentage of participants with major adverse events

Time frame
up to 12 months
3

Number of participants with severe adverse events

Number of participants with severe adverse events

Time frame
up to 30 days, up to 6 months, up to 5 years
4

Number of patients with readmission for HF

First unplanned readmission for Heart Failure

Time frame
up to 5 years

Other outcomes

Sponsors and contacts

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