Frontlight ResearchEarly access
Active, not recruitingNo phase
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
Key facts
- Who runs it
- Abbott Medical Devices
- Where
- Minneapolis, New York, The Bronx, and Wichita, United StatesSee the 4 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 11 people enrolled
- Started
- 30 Oct 2025
- Expected to end
- Jun 2031
- Type of study
- Interventional
- Treatments tested
- Abbott BE TAVI System
- Record updated
- 6 February 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Life expectancy for a condition other than aortic stenosis is less than 2 years
- Presence of other anatomic or comorbid conditions
- Evidence of an acute myocardial infarction
- Untreated clinically significant coronary artery disease requiring revascularization
- Liver failure
- Pregnant or nursing subjects
- Incapacitated individuals
- Severe mitral regurgitation or severe mitral stenosis
- etc
Where in United States
Also in 1 other country, 1 site
- Abbott-Northwestern HospitalMinneapolis, United States
- Columbia University Medical Center New York PresbyterianNew York, United States
- Montefiore Medical Center - Moses DivisionThe Bronx, United States
- Via Christi Regional Medical CenterWichita, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- BE TAVI SystemTreatment being tested
Treatment: Abbott BE TAVI System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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
- Record updated
- 6 February 2026