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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-30

Study Completion Date

2031-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Symptomatic Severe Aortic Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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BE TAVI System

Group Type EXPERIMENTAL

Abbott BE TAVI System

Intervention Type DEVICE

Abbott BE TAVI System

Interventions

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Abbott BE TAVI System

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes