EFS of the DUO System for Tricuspid Regurgitation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCroiValve Limited

About this trial

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Eligibility criteria

Qualifiers

Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.

Patient is symptomatic despite medical therapy.

The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.

The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.

Disqualifiers

Patient is currently participating in another clinical investigation that could affect the outcome of this trial.

Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.

Moderate or greater tricuspid valve stenosis.

Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation

Trial design

Treatments tested in this trial

  • DUO Transcatheter Tricuspid Coaptation Valve System

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators