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.
Brief Title
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
Detailed Description
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.
Completion Date
Completion Date Type
Estimated
Conditions
Symptomatic Severe Aortic Stenosis
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Balloon Expandable TAVI
TAVI
Treatment of patient with symptomatic severe aortic valve stenosis
aortic stenosis
cardiovascular disease
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07116551
Org Class
Industry
Org Full Name
Abbott Medical Devices
Org Study Id
ABT-CIP-10541
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.
Outcome Measure
Technical success
Outcome Time Frame
From start of procedure up to end of procedure
Outcome Description
Intended performance of the valve
Outcome Measure
Device success
Outcome Time Frame
30 days
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076
Investigator Department
Medicine
Investigator Division
Cardiology
Investigator Sponsor Organization
Montefiore
Study Department
Medicine
Study Division
Cardiology
Categories Mesh Debug
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- HEART VALVE DISEASES
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
MeSH Terms
AORTIC VALVE STENOSIS
CARDIOVASCULAR DISEASES
AORTIC VALVE DISEASE
HEART VALVE DISEASES
HEART DISEASES
VENTRICULAR OUTFLOW OBSTRUCTION