A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation

Launched by CROIVALVE LIMITED · Mar 15, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option called the CroíValve DUO System for patients with severe tricuspid regurgitation, which is a condition where the heart's tricuspid valve does not close properly, causing blood to flow backward into the heart. The study aims to see how safe and effective this new device is for people who are experiencing symptoms despite being on medication. It is currently recruiting participants aged 18 and older who have been diagnosed with severe tricuspid regurgitation and are still having symptoms that impact their daily lives.

To be eligible, participants must have a specific assessment confirming their condition and should not have had previous surgeries on the tricuspid valve. They also need to be stable on their current heart medications. In this study, participants will receive the new valve system and will be monitored for safety and performance. It's important to know that there are several health conditions and factors that might prevent someone from joining the trial, so potential participants will go through a screening process to determine their eligibility.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Presence of severe Tricuspid Regurgitation per American Society of Echocardiography (ASE) Criteria determined by Echo Core Lab assessment of a qualifying Transthoracic Echocardiogram (TTE).
• • 2. Subject is symptomatic despite medical therapy (NYHA Functional Class II or higher)
• • 3. Subject is on stable medical therapy as assessed by the Heart Team
• • 4. The patient's anatomy is suitable in the judgment of the Investigational Site Heart Team and the Patient Screening Committee.
• • 5. Age ≥18 years
• • 6. 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:
• • 1. Subject is currently participating in another clinical investigation that could affect the outcome of this trial
• • 2. Transesophageal echocardiography (TEE) is contraindicated or unsuccessful
• • 3. Previous tricuspid valve repair, replacement or transcatheter tricuspid intervention
• • 4. Moderate to severe tricuspid valve stenosis
• • 5. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
• • 6. 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
• • 7. Need for concomitant surgical or interventional procedure known at time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
• • 8. Ejection Fraction (EF) \<30% within 45 days of the implant procedure
• • 9. Echocardiographic or CT evidence of intracardiac mass, thrombus or vegetation
• • 10. Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg
• • 11. Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
• • 12. Severe respiratory instability: Severe COPD or continuous use of home oxygen or has FEV1 \<50% of predicted
• • 13. Severe right ventricular dysfunction as determined by the Echo Core Lab
• • 14. Untreated clinically significant coronary artery disease requiring revascularization surgical or interventional PCI
• • 15. Stroke or transient ischemic event within 90 days prior to the implant procedure
• • 16. Untreated severe symptomatic carotid stenosis (\>70% by ultrasound)
• • 17. Acute myocardial infarction within 30 days before the index procedure
• • 18. Renal insufficiency (eGFR\<25 ml/min)
• • 19. Active endocarditis within 6 months of the implant procedure
• • 20. Pulmonary embolism within the last 6 months
• • 21. Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure
• • 22. Patient has an SVC dimension/anatomy is not suitable for device implantation (i.e., extremely tortuous, heavily calcified, aneurysmal)
• • 23. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
• • 24. Life expectancy \<1 year
• • 25. Active infections requiring current antibiotic therapy
• • 26. Known severe liver disease
• • 27. Prior heart or lung transplant
• • 28. Known active peptic ulcer or active GI bleed
• • 29. Unable to take anticoagulant therapy
• • 30. Known patient is actively abusing drugs
• • 31. Subjects who are pregnant or planning to become pregnant
• • 32. 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
• • 33. Any known major coagulation abnormalities, thrombocytopenia, platelets \<50,0000/ml or anemia Hb \<9g/dl
• • 34. Any known sensitivities or allergies to contrast and/or the device materials, including nickel and titanium
• • 35. BMI \>50kg/m2
• • 36. Transvalvular implanted pacemaker or ICD lead is present