Status:
ACTIVE_NOT_RECRUITING
A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation
Lead Sponsor:
CroiValve Limited
Conditions:
Tricuspid Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05296148
Start Date
June 17 2022
End Date
July 31 2026
Last Update
July 31 2025
Active Locations (3)
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1
Uniwersyteckie Centrum Kliniczne GUMed
Gdansk, Poland
2
Górnośląskie Centrum Medyczne im. Prof. Leszka Gieca
Katowice, Poland
3
Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńskiego
Warsaw, Poland