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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07116551

Enrollment

Registered

2025-08-11

Start date

2025-10-30

Completion date

2031-06-01

Last updated

2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Severe Aortic Stenosis

Keywords

Balloon Expandable TAVI, TAVI, Treatment of patient with symptomatic severe aortic valve stenosis, aortic stenosis, cardiovascular disease

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.

Interventions

DEVICEAbbott BE TAVI System

Abbott BE TAVI System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France, United States

Contacts

STUDY_DIRECTORAshish Oza

Abbott Structural Heart

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026