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

Running, not enrolling · Not applicable

Conditions studied: Symptomatic Severe Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT07116551

Run by

Abbott Medical Devices

People needed

11

Starts

2025-10-30

Expected to finish

2031-06-01

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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