Clinical Trial

Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis

Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-08; most recent amendment 2026-02-05.
Status change: Recruiting → Active, Not Recruiting 2026-02-05
Status change: Not Yet Recruiting → Recruiting 2025-11-04
Trial Details
NCT Number NCT07116551
Lead Sponsor Abbott Medical Devices
Conditions Symptomatic Severe Aortic Stenosis
Enrollment 11 participants
Start Date 2025-10-30
Primary Completion 2031-06 (estimated)
Study Completion 2031-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-06