Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation

CroiValve Limited16 sites in 2 countries15 target enrollmentAugust 13, 2024

ConditionsTricuspid Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease Heart Valve Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tricuspid Regurgitation
Sponsor: CroiValve Limited
Enrollment: 15
Locations: 16
Primary Endpoint: Freedom from device or procedure related MAEs
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Detailed Description

Multi-center, prospective, non-randomized, investigational, and pre-market. Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes.

Registry

clinicaltrials.gov

Start Date

August 13, 2024

End Date

October 1, 2029

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CroiValve Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Age ≥18 years
•The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.

Exclusion Criteria

•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
•Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
•Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
•Ejection Fraction (EF) \<25%
•Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation
•Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg
•Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices

Outcomes

Primary Outcomes

Freedom from device or procedure related MAEs

Time Frame: At 30 days

* Death * Reintervention * Disabling stroke * Myocardial infarction * Major access site and vascular complications * Severe bleeding * Renal failure requiring dialysis * Major cardiac structural complications * Pulmonary embolism