Symptomatic Severe Aortic Stenosis
Conditions
Keywords
Balloon Expandable TAVI, Transcatheter aortic valve implantation (TAVI), Treatment of patients with symptomatic severe aortic valve stenosis, Aortic stenosis, Cardiovascular disease
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.
Interventions
DEVICEBalloon expandable TAVI
Prospective, single-arm, multi-center early experience study.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Georgia, Uzbekistan
Contacts
STUDY_DIRECTORAshish Oza
Abbott Structural Heart
Outcome results
None listed