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Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
Sponsor: Abbott Medical Devices
Summary
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.
Official title: Abbott BE TAVI Early Feasibility Study: Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11
Start Date
2025-10-30
Completion Date
2031-06
Last Updated
2026-02-06
Healthy Volunteers
Yes
Conditions
Interventions
Abbott BE TAVI System
Abbott BE TAVI System
Locations (5)
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
Clinique Pasteur Toulouse
Toulouse, Midpyre, France