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NCT Number: NCT07116551

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Symptomatic Severe Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Pasteur Toulouse, Toulouse, Midpyre, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abbott BE TAVI System

Device

Abbott BE TAVI System

Primary outcomes

  1. Technical success

    Time frame: From start of procedure up to end of procedure

    Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.

  2. Device success

    Time frame: 30 days

    Intended performance of the valve

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Aug 11, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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