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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Subject is at least 18 years of age
• Subject is able and willing to return for required follow-up visits and assessments
• Degenerative severe aortic valve stenosis of the native aortic valve with echo-derived criteria
Locations
United States
Kansas
Via Christi Regional Medical Center
RECRUITING
Wichita
Minnesota
Abbott Northwestern Hospital
RECRUITING
Minneapolis
New York
Columbia University Medical Center/New York-Presbyterian
NOT_YET_RECRUITING
New York
Montefiore Medical Center - Moses Division
NOT_YET_RECRUITING
The Bronx
Contact Information
Primary
George Galoussian
george.galoussian@abbott.com
+1 818 49 32 156
Backup
Nels Engblom
nels.engblom1@abbott.com
+1 319 853 3946
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2031-06
Participants
Target number of participants: 20
Treatments
Experimental: BE TAVI System
BE TAVI System
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices