EFS of the DUO System for Tricuspid Regurgitation (TANDEM II)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases

Intervention / Treatment
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* Device: DUO Transcatheter Tricuspid Coaptation Valve System


Participation Criteria
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Eligibility Criteria
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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 Severe respiratory instability with continuous use of home oxygen Severe right ventricular dysfunction Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI. Stroke or transient ischemic event within 90 days prior to the index procedure Acute myocardial infarction within 30 days before the index procedure Renal insufficiency (eGFR <25 ml/min) or currently on chronic dialysis Active endocarditis within 6 months of the index procedure Pulmonary embolism or deep vein thrombosis within the last 6 months Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis Life expectancy <1 year Active infections requiring current antibiotic therapy Known severe liver disease Is on the waiting list for a transplant or has had a prior heart or lung transplant Known active peptic ulcer or active GI bleed Unable to take anticoagulant therapy Any known major coagulation abnormalities, thrombocytopenia, platelets < 50,000/ml or severe anemia Hb <8 g/dl Known patient is actively abusing drugs Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium Patients who are pregnant or intend to become pregnant Any condition making it unlikely the Patient will be able to complete all protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System) | Device: DUO Transcatheter Tricuspid Coaptation Valve System<br>* Reduction of tricuspid regurgitation through a transcatheter approach<br>* Other names: DUO System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device or procedure related MAEs | Death Reintervention Disabling stroke Myocardial infarction Major access site and vascular complications Severe bleeding Renal failure requiring dialysis Major cardiac structural complications Pulmonary embolism | At 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tricuspid, TR, Transcatheter, Coaptation Valve, SVC