A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation

Study Overview
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Brief Summary
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This study is prospective, multicentre, non-randomized single-arm early feasibility study to evaluate the safety and performance of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in patients with severe Tricuspid Regurgitation.

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

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Device: Transcatheter Tricuspid Valve Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of severe Tricuspid Regurgitation per American Society of Echocardiography (ASE) Criteria determined by Echo Core Lab assessment of a qualifying Transthoracic Echocardiogram (TTE). Subject is symptomatic despite medical therapy (NYHA Functional Class II or higher) Subject is on stable medical therapy as assessed by the Heart Team The patient's anatomy is suitable in the judgment of the Investigational Site Heart Team and the Patient Screening Committee. Age ≥18 years The patient or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the EC of the respective clinical site. Exclusion Criteria: Subject is currently participating in another clinical investigation that could affect the outcome of this trial Transesophageal echocardiography (TEE) is contraindicated or unsuccessful Previous tricuspid valve repair, replacement or transcatheter tricuspid intervention Moderate to severe tricuspid valve stenosis Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation Significant comorbid factors which places the subject at prohibitive risk for surgical repair in the judgment of the Investigational Site Heart Team and the Patient Screening Committee Need for concomitant surgical or interventional procedure known at time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair). Ejection Fraction (EF) <30% within 45 days of the implant procedure Echocardiographic or CT evidence of 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: Severe COPD or continuous use of home oxygen or has FEV1 <50% of predicted Severe right ventricular dysfunction as determined by the Echo Core Lab Untreated clinically significant coronary artery disease requiring revascularization surgical or interventional PCI Stroke or transient ischemic event within 90 days prior to the implant procedure Untreated severe symptomatic carotid stenosis (>70% by ultrasound) Acute myocardial infarction within 30 days before the index procedure Renal insufficiency (eGFR<25 ml/min) Active endocarditis within 6 months of the implant procedure Pulmonary embolism within the last 6 months Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure Patient has an SVC dimension/anatomy is not suitable for device implantation (i.e., extremely tortuous, heavily calcified, aneurysmal) Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis Life expectancy <1 year Active infections requiring current antibiotic therapy Known severe liver disease Prior heart or lung transplant Known active peptic ulcer or active GI bleed Unable to take anticoagulant therapy Known patient is actively abusing drugs Subjects who are pregnant or planning to become pregnant Any condition making it unlikely the subject will be able to complete all protocol procedures (including compliance with guideline-directed medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result Any known major coagulation abnormalities, thrombocytopenia, platelets <50,0000/ml or anemia Hb <9g/dl Any known sensitivities or allergies to contrast and/or the device materials, including nickel and titanium BMI >50kg/m2 Transvalvular implanted pacemaker or ICD lead is present

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 CroíValve DUO Coaptation Valve System | Device: Transcatheter Tricuspid Valve Implantation<br>* Implantation of a tricuspid coaptation valve through a transcatheter approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device or procedure related serious adverse events | Freedom from device or procedure related serious adverse events | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TR Grade | Number of patients with reduction in TR from baseline as assessed by echocardiography | Day 30, Month 6, Month 12 | 
| NHYA Functional Class | Number of patients with improvement in NYHA class | Day 30, Month 6, Month 12 | 
| Six Minute Walk Test (6MWT) | Change in distance (m) from baseline | Day 30, Month 6, Month 12 |