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ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
 
Region Sponsors
California - Northern
Edwards Lifesciences
 
Acronym KP IRB No.
ALLIANCE 1975316
 
Study Type Phase
Prospective Cohort Study with Direct Patient Contact
 
Study Population Description
(Child, Adult, Older Adult) Male and Female with Aortic Stenosis, Severe
 
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).
 
Detailed Description
This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Severe, calcific AS
  • Native aortic annulus size suitable for SAPIEN X4 THV
  • NYHA functional class >II
  • The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent
 
Exclusion Criteria
  • Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
  • Aortic valve is unicuspid, bicuspid or non-calcified
  • Pre-existing mechanical or bioprosthetic valve in any position
  • Severe aortic regurgitation (> 3+)
  • Severe mitral regurgitation (> 3+) or = moderate mitral stenosis
  • Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
  • Please contact study team for additional exclusion criteria

 
Keywords and/or Specific Medical Conditions
  • Aortic Valve Disease
  • SAPIEN X4
  • Aortic Valve Stenosis
  • Transcatheter aortic valve implantation (TAVI)
  • Cardiovascular Diseases
  • Transcatheter aortic valve replacement (TAVR)
  • Heart Diseases
  • Ventricular Outflow Obstruction
  • Heart Valve Diseases
  • Cardiology
 
KP Clinical Facility
  • San Francisco Medical Center
 
Clinical Area
  • Cardiology


Principal Investigator:
Jacob Mishell , MD
Contact Information:
- Quyen X Chau
-Quyen.X.Chau@kp.org
-San Francisco Medical Center


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