AMPLATZER Amulet LAA Occluder Trial (Amulet IDE)
Sponsor: |
St. Jude Medical |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAR6157 |
U.S. Govt. ID: |
NCT02879448 |
Contact: |
Lauren Privitera: 212-342-3488 / lp2183@cumc.columbia.edu |
The Amulet IDE trial is a prospective, randomized, multi-center active control worldwide trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device (treatment) or a Boston Scientific WATCHMAN LAA closure device (Control). The trial will be conducted at up to 150 sites worldwide. All enrolled subjects will follow the protocol-required tests and assessments at each scheduled follow-up visit.
This study is closed
Investigator
Robert Sommer, MD
Are you 18 years or older? |
Yes |
No |
Are you at risk for stroke? |
Yes |
No |