Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study
Not Applicable
Active, not recruiting
- Conditions
- Symptomatic Severe Aortic Stenosis
- Registration Number
- NCT07082426
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
Early System Experience with the Abbott Balloon-expandable TAVI System
- Detailed Description
The Early System Experience with the Abbott's balloon-expandable TAVI System first-in-human study ('EASE study') will evaluate preliminary clinical evidence on the safety and feasibility of the Abbott's balloon-expandable TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Increased surgical risk
- Appropriate anatomy
- At least 18 years of age
- Willing to return for follow-up assessments
Exclusion Criteria
- Pregnant or nursing subjects
- Anatomic or comorbid conditions
- Evidence of acute myocardial infarction
- Inoperable/ineligible for surgery
- Renal disease requiring chronic dialysis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Technical Success Post 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Israeli - Georgian Medical Research Clinic Healthycore
🇬🇪Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic
🇬🇪Tbilisi, Georgia
Republican Centre of Emergency Medicine
🇺🇿Tashkent, Toshknt, Uzbekistan
Israeli - Georgian Medical Research Clinic Healthycore🇬🇪Tbilisi, Georgia