Colibri Transcatheter Aortic Heart Valve System Study

This is an interventional treatment trial for Severe Aortic Stenosis Read More

Inclusion Criteria:

• 1. Subject of age > 75 years
• 2. Subject suffering from severe aortic tricuspid valve stenosis defined as follows: High-gradient aortic stenosis (mean pressure gradient across aortic valve > 40 mmHg or peak velocity > 4.0 m/s)
• 3. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) > Class II
• 4. Subject with a documented local Heart Team (HT) agreement of high surgical risk as described in the population
• 5. ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus > 22 mm and < 27.4 mm
• 6. Subject deemed eligible by a TAVI Centralized Case Review Committee (CRC)
• 7. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow-up requirements

Exclusion Criteria:

• 1. Arterial aorto-iliac-femoral axis unsuitable for transfemoral access as assessed by conventional angiography and/or multidetector computed tomographic angiography (access vessel diameter incompatible with a 16F sheath introducer)
• 2. Aortic root anatomy condition or lesion preventing implantation or access to the aortic valve
• 3. Non-calcific acquired aortic stenosis
• 4. Native unicuspid/bicuspid aortic valve or congenital aortic valve abnormality
• 5. Previous implantation of heart valve in any position
• 6. Severe aortic regurgitation (> 3+)
• 7. Severe mitral regurgitation (> 3+)
• 8. Severe tricuspid regurgitation (> 3+)
• 9. Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) < 30%)
• 10. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• 11. Multi-vessel coronary artery disease (CAD) with a Syntax Score or residual Syntax Score > 22 and/or unprotected left main coronary artery
• 12. Cardiogenic shock
• 13. Untreated cardiac conduction disease in need of pacemaker implantation
• 14. Uncontrolled atrial fibrillation (resting heart rate (HR) > 120bpm)
• 15. Active and/or suspicion of endocarditis or ongoing sepsis
• 16. Blood dyscrasias defined as: leukopenia (White Blood Cells (WBC) < 1,000/mm3), thrombocytopenia (Platelets (PLT) < 50,000/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
• 17. Evidence of acute myocardial infarction (MI) less than 30 days before signing informed consent
• 18. Any need for emergency surgery
• 19. Recent (< 6 months of signing informed consent) CerebroVascular Accident (CVA) or Transient Ischemic Attack (TIA)
• 20. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis < 30 days prior to signing informed consent
• 21. Any active bleeding that precludes anticoagulation
• 22. Liver failure (Child-C)
• 23. End-stage renal disease requiring chronic dialysis or creatinine clearance < 20cc/min
• 24. Pulmonary hypertension (systolic pressure >80mmHg)
• 25. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by a Forced Expiratory Volume (FEV1) < 750cc
• 26. Refusal of blood transfusion
• 27. A known hypersensitivity or contraindication to all anticoagulation/anti-platelet regimens (or inability to be anticoagulated for the index procedure), to cobalt chromium, to porcine and/or collagen, to glutaraldehyde or contrast media
• 28. Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow-up procedures
• 29. Currently participating in another drug or device trial (excluding observational registries) for which the primary endpoint has not been assessed
• 30. Estimated life expectancy of less than 12 months
• 31. For females, pregnancy or intention to become pregnant prior to completion of all follow-up procedures
• 32. Inability to comply with the clinical investigation requirements
• 33. Subject under judicial protection, tutorship or curatorship (for France only)