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

Last updated: December 10, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Treatment

Abbott BE TAVI System

Clinical Study ID

NCT07116551
ABT-CIP-10541
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 withecho-derived criteria

Exclusion

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.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Abbott BE TAVI System
Phase:
Study Start date:
October 30, 2025
Estimated Completion Date:
June 30, 2031

Study 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.

Connect with a study center

  • Via Christi Regional Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Via Christi Regional Medical Center

    Wichita 4281730, Kansas 4273857 67214
    United States

    Active - Recruiting

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Abbott Northwestern Hospital

    Minneapolis 5037649, Minnesota 5037779 55407
    United States

    Active - Recruiting

  • Montefiore Medical Center - Moses Division

    Bronx, New York 10461
    United States

    Site Not Available

  • Columbia University Medical Center/New York-Presbyterian

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • New York Presbyterian/Columbia University

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Montefiore Medical Center - Moses Division

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

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