Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study
NCT07082426 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2026-04-08
Summary
Early System Experience with the Abbott Balloon-expandable TAVI System
Conditions
- Symptomatic Severe Aortic Stenosis
Interventions
- DEVICE
-
Balloon expandable TAVI
Prospective, single-arm, multi-center early experience study.
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
Ashish Oza · Abbott Structural Heart
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-21
- Primary Completion
- 2027-08-30
- Completion
- 2027-09-30
- FDA Device
- Yes
Countries
- Georgia
- Uzbekistan
Study Locations
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