ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Trial ID or NCT#

NCT05172960

Status

recruiting iconRECRUITING

Purpose

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Official Title

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Severe, calcific AS2. Native aortic annulus size suitable for SAPIEN X4 THV3. NYHA functional class ≥ II4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria:
  1. 1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system2. Aortic valve is unicuspid, bicuspid or non-calcified3. Pre-existing mechanical or bioprosthetic valve in any position4. Severe aortic regurgitation (\> 3+)5. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis6. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months7. Left ventricular ejection fraction \< 20%8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation10. Increased risk of coronary artery obstruction after THV implantation11. Myocardial infarction within 30 days prior to the study procedure12. Hypertrophic cardiomyopathy with subvalvular obstruction13. Subjects with planned concomitant ablation for atrial fibrillation14. 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 procedure18. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure19. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure20. Renal insufficiency and/or renal replacement therapy21. Leukopenia, anemia, thrombocytopenia22. Inability to tolerate or condition precluding treatment with antithrombotic therapy23. Hypercoagulable state or other condition that increases risk of thrombosis24. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication25. Subject refuses blood products26. BMI \> 50 kg/m227. Estimated life expectancy \< 24 months28. Female who is pregnant or lactating29. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments30. Participating in another investigational drug or device study that has not reached its primary endpoint31. Subject considered to be part of a vulnerable population
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Investigator(s)

Rahul P Sharma, MBBS, FRACP
Cardiologist, Interventional cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Christiane Haeffele
Christiane Haeffele
Cardiologist, Adult congenital heart disease cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology

View on ClinicalTrials.gov