Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
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
1 other identifier
interventional
11
2 countries
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2025
CompletedFirst Posted
Study publicly available on registry
August 11, 2025
CompletedStudy Start
First participant enrolled
October 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
February 6, 2026
February 1, 2026
5.6 years
July 22, 2025
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Technical success
Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.
From start of procedure up to end of procedure
Device success
Intended performance of the valve
30 days
Study Arms (1)
BE TAVI System
EXPERIMENTALBE TAVI System
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Columbia University Medical Center/New York-Presbyterian
New York, New York, 10032, United States
Montefiore Medical Center - Moses Division
The Bronx, New York, 10461, United States
Clinique Pasteur Toulouse
Toulouse, Midpyre, 31076, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ashish Oza
Abbott Structural Heart
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2025
First Posted
August 11, 2025
Study Start
October 30, 2025
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
June 1, 2031
Last Updated
February 6, 2026
Record last verified: 2026-02