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

Not Applicable

Not yet recruiting

• Conditions: Symptomatic Severe Aortic Stenosis

• Registration Number: NCT07116551
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2025-07-22
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Start: 2025-10-24
• Primary Completion: 2031-06
• Study Completion: 2031-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnant or nursing subjects
• Life expectancy for a condition other than aortic stenosis is less than 2 years
• Presence of other anatomic or comorbid conditions
• Incapacitated individuals
• Evidence of an acute myocardial infarction
• Untreated clinically significant coronary artery disease requiring revascularization
• Liver failure
• Severe mitral regurgitation or severe mitral stenosis
• etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Technical success	From start of procedure up to end of procedure	Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.
Device success	30 days	Intended performance of the valve

Trial Locations

Locations (3)

Via Christi Regional Medical Center; 🇺🇸 Wichita, Kansas, United States

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States

Montefiore Medical Center - Moses Division; 🇺🇸 Bronx, New York, United States