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Clinical Trials in France / NCT07116551
Active, not recruiting Not applicable

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

NCT07116551 · tracked via the Priya Life Science France tracker
Sponsor
Abbott Medical Devices
Phase
Not applicable
Started
2025-10-30
Last updated
2026-02-06

Condition(s) studied

Symptomatic Severe Aortic Stenosis

Investigational drug(s) / intervention(s)

Abbott BE TAVI System

Abbott BE TAVI System: Abbott BE TAVI System

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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

Trial sites (5)

FacilityCityRegionStatus
Via Christi Regional Medical Center Wichita Kansas
Abbott Northwestern Hospital Minneapolis Minnesota
Columbia University Medical Center/New York-Presbyterian New York New York
Montefiore Medical Center - Moses Division The Bronx New York
Clinique Pasteur Toulouse Toulouse Midpyre

More Abbott Medical Devices trials in France

Valved Graft PMCF Study Recruiting
SyncAV Post-Market Trial Active, not recruiting
Abbott Medical - VERITAS Study Active, not recruiting
Abbott DBS Post-Market Study of Outcomes for Indications Over Time Recruiting
Abbott Vascular Medical Device Registry Recruiting

Other trials for the same condition

Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation Active, not recruiting
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07116551 on ClinicalTrials.gov ↗ ← All trials in France