RecruitingTricuspid RegurgitationTricuspid Valve InsufficiencyTricuspid Valve Disease

EFS of the DUO System for Tricuspid Regurgitation

Eligible age

18+ yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

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).

Sponsor: CroiValve Limited

You may qualify if…

✓ 1. Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
✓ 2. Patient is symptomatic despite medical therapy.
✓ 3. The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
✓ 4. The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
✓ 5. Age ≥18 years
✓ 6. The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.

You may not qualify if…

✕ 1. Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
✕ 2. Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
✕ 3. Moderate or greater tricuspid valve stenosis.
✕ 4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
✕ 5. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
✕ 6. Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
✕ 7. Ejection Fraction (EF) \<25%
✕ 8. Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation