What is the Purpose of this Study?
The purpose of this study is to determine whether an investigational device called the Sapien X4 Transcatheter Heart Valve system is beneficial for patients with symptomatic, severe, calcific aortic stenosis. Aortic stenosis is a condition in which the opening of the heart valve becomes smaller, making it more difficult for the heart to pump blood. In this study, participants will have their valve replaced by the Sapien X4 Transcatheter Heart Valve system, which includes an artificial heart valve and accessories used to implant the valve. Each valve consists of a stent (metal mesh tube) made of a metal frame with knitted fabric covering some of the frame. The SAPIEN X4 delivery system consists of a catheter (a long, thin, bendable tube that is placed in a blood vessel) that is inserted through an incision made in the groin and moved through blood vessels to the heart.
Eligibility
- 1. Severe, calcific AS
- 2. Native aortic annulus size suitable for SAPIEN X4 THV
- 3. NYHA functional class ≥ II
- 4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
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Inclusion Criteria:
- 1. Severe, calcific AS
- 2. Native aortic annulus size suitable for SAPIEN X4 THV
- 3. NYHA functional class ≥ II
- 4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria:
- 1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
- 2. Aortic valve is unicuspid, bicuspid or non-calcified
- 3. Pre-existing mechanical or bioprosthetic valve in any position
- 4. Severe aortic regurgitation (\> 3+)
- 5. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
- 6. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
- 7. Left ventricular ejection fraction \< 20%
- 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation
- 10. Increased risk of coronary artery obstruction after THV implantation
- 11. Myocardial infarction within 30 days prior to the study procedure
- 12. Hypertrophic cardiomyopathy with subvalvular obstruction
- 13. Subjects with planned concomitant ablation for atrial fibrillation
- 14. Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
- 15. Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
- 16. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)
- 17. Endocarditis within 180 days prior to the study procedure
- 18. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
- 19. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
- 20. Renal insufficiency and/or renal replacement therapy
- 21. Leukopenia, anemia, thrombocytopenia
- 22. Inability to tolerate or condition precluding treatment with antithrombotic therapy
- 23. Hypercoagulable state or other condition that increases risk of thrombosis
- 24. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
- 25. Subject refuses blood products
- 26. BMI \> 50 kg/m2
- 27. Estimated life expectancy \< 24 months
- 28. Female who is pregnant or lactating
- 29. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- 30. Participating in another investigational drug or device study that has not reached its primary endpoint
- 31. Subject considered to be part of a vulnerable population
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Safety and Effectiveness of Balloon-Expanding Bioprosthetic Sapien X4 Trascather Heart Valve -ALLIANCE Study