EFS of the DUO System for Tricuspid Regurgitation

Launched by CROIVALVE LIMITED · Jun 12, 2023

Keywords

ClinConnect Summary

The TANDEM II trial is studying a new device called the DUO Transcatheter Tricuspid Coaptation Valve System, which is designed to help patients with a heart condition known as tricuspid regurgitation. This condition occurs when the tricuspid valve doesn't close properly, causing blood to flow backward in the heart. The trial aims to see how safe and effective this device is for patients who continue to experience symptoms despite taking medications.

To participate in this study, individuals must be at least 18 years old and have severe tricuspid regurgitation that is causing them symptoms. They should also be deemed suitable for this type of valve procedure by their local heart team. Participants will receive the investigational device and will be monitored closely to assess their health outcomes. It's important to note that certain health conditions, like severe valve problems or recent heart surgeries, may prevent someone from joining the trial. If you or someone you know is dealing with this heart issue, discussing participation with a healthcare provider could be a good next step.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
• • 2. Patient is symptomatic despite medical therapy.
• • 3. The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
• • 4. The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
• • 5. Age ≥18 years
• • 6. The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.
• Exclusion Criteria:
• • 1. Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
• • 2. Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
• • 3. Moderate or greater tricuspid valve stenosis.
• • 4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
• • 5. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
• • 6. Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
• • 7. Ejection Fraction (EF) \<25%
• • 8. Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation
• • 9. Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg
• • 10. Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
• • 11. Severe respiratory instability with continuous use of home oxygen
• • 12. Severe right ventricular dysfunction
• • 13. Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI.
• • 14. Stroke or transient ischemic event within 90 days prior to the index procedure
• • 15. Acute myocardial infarction within 30 days before the index procedure
• • 16. Renal insufficiency (eGFR \<25 ml/min) or currently on chronic dialysis
• • 17. Active endocarditis within 6 months of the index procedure
• • 18. Pulmonary embolism or deep vein thrombosis within the last 6 months
• • 19. Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure
• • 20. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
• • 21. Life expectancy \<1 year
• • 22. Active infections requiring current antibiotic therapy
• • 23. Known severe liver disease
• • 24. Is on the waiting list for a transplant or has had a prior heart or lung transplant
• • 25. Known active peptic ulcer or active GI bleed
• • 26. Unable to take anticoagulant therapy
• • 27. Any known major coagulation abnormalities, thrombocytopenia, platelets \< 50,000/ml or severe anemia Hb \<8 g/dl
• • 28. Known patient is actively abusing drugs
• • 29. Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium
• • 30. Patients who are pregnant or intend to become pregnant
• • 31. 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