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

Launched by ABBOTT MEDICAL DEVICES · Aug 8, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Abbott’s Balloon-expandable TAVI system for people with severe aortic stenosis. Aortic stenosis is a condition where the valve in the heart that controls blood flow narrows, making it hard for the heart to pump blood properly. This study wants to see if this new device is safe and works well for patients who have symptoms from this condition.

Adults aged 65 to 74 with severe aortic valve narrowing may be able to join the study, as long as they can come back for follow-up visits and don’t have other serious health problems like liver failure or untreated heart issues. Participants will receive the new valve treatment and will be monitored to check how well it works and if there are any side effects. The trial is not yet recruiting, so if you or a loved one fits these criteria and are interested, it’s a good idea to talk with your doctor about this option.

Gender

ALL

Eligibility criteria

• 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.