ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
ConditionAortic Stenosis, Severe
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEdwards Lifesciences
About this trial
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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+)
Trial design
Treatments tested in this trial
- SAPIEN X4 THV
- SAPIEN X4S
Treatment groups
1,234 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov