5172960
Last Update Posted: 2024-12-10
Recruiting has ended
All Genders accepted | Under |
915 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
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).
This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.
Eligibility
Relevant conditions:
Aortic Stenosis, Severe
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Contact Information
Overall Contact
Edwards THV Clinical Affairs
THV_CT.gov@Edwards.com
949-250-2500
Data sourced from ClinicalTrials.gov