NCT05296148Active, not recruitingNot Applicable
A European Feasibility Study of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation
CroiValve Limited3 sites in 1 country10 target enrollmentStarted: June 17, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 3
- Primary Endpoint
- Freedom from device or procedure related serious adverse events
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment
Experimental
Treatment with the CroíValve DUO Coaptation Valve System
Intervention: Transcatheter Tricuspid Valve Implantation (Device)
Outcomes
Primary Outcomes
Freedom from device or procedure related serious adverse events
Time Frame: Day 30
Freedom from device or procedure related serious adverse events
Secondary Outcomes
- NHYA Functional Class(Day 30, Month 6, Month 12)
- Six Minute Walk Test (6MWT)(Day 30, Month 6, Month 12)
- Change in TR Grade(Day 30, Month 6, Month 12)
Investigators
Study Sites (3)
Loading locations...
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