The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
The EFS will evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
11
Abbott BE TAVI System
Via Christi Regional Medical Center
Wichita, Kansas, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Columbia University Medical Center/New York-Presbyterian
New York, New York, United States
Montefiore Medical Center - Moses Division
The Bronx, New York, United States
Technical success
Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.
Time frame: From start of procedure up to end of procedure
Device success
Intended performance of the valve
Time frame: 30 days
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Clinique Pasteur Toulouse
Toulouse, Midpyre, France