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

Abbott

Status: Active, not recruiting

Conditions: Symptomatic Severe Aortic Stenosis

Treatments: Device: Abbott BE TAVI System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07116551

ABT-CIP-10541

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

BE TAVI System

Experimental group

Description:

BE TAVI System

Treatment:

Device: Abbott BE TAVI System