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

a study on Aortic Stenosis

Summary

Location
at UC Davis
Dates
study started
completion around

Description

Summary

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

Details

This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.

Keywords

Aortic Stenosis, Severe, Transcatheter aortic valve replacement (TAVR), Transcatheter aortic valve implantation (TAVI), SAPIEN X4, Aortic Valve Stenosis, SAPIEN X4 THV, TAVR - Bicuspid Registry

Eligibility

You can join if…

  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.

You CAN'T join if...

  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

Locations

  • UC Davis Medical Center Sacramento accepting new patients
    Sacramento California 95817 United States
  • Kaiser San Francisco Medical Center accepting new patients
    San Francisco California 94115 United States
  • Scripps Memorial Hospital La Jolla accepting new patients
    La Jolla California 92037 United States
  • Bay Area Structural Heart at Sutter Health accepting new patients
    San Francisco California 94109 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States
  • Kaiser Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT05172960
Study Type
Interventional
Participants
Expecting 915 study participants
Last Updated