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ACTIVE NOT RECRUITING
NCT07116551
NA

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

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2025-10-30

Completion Date

2031-06

Last Updated

2026-02-06

Healthy Volunteers

Yes

Interventions

DEVICE

Abbott BE TAVI System

Abbott BE TAVI System

Locations (5)

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