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 USA 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)

Facility	City	Region
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 the USA

CardioMEMS HF System Real-World Evidence Post-Approval Study Enrolling by invitation

PARADIGM: Amplatzer Valvular Plug for PVL Closure Active, not recruiting

Abbott Vascular Medical Device Registry Recruiting

ViewFlex X ICE First-in-Human Study Recruiting

Esprit BTK Post-Approval Study Active, not recruiting

Other trials for the same condition

Portico Next Generation Approval Study Active, not 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 the USA