NCT07082426

Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study

EASE Study: Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Symptomatic Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Balloon expandable TAVI	Prospective, single-arm, multi-center early experience study.

Timeline

• Start date: 2024-11-21
• Primary completion: 2027-08-30
• Completion: 2027-09-01
• First posted: 2025-07-24
• Last updated: 2026-04-08

Locations

3 sites across 2 countries: Georgia, Uzbekistan

Regulatory

• FDA-regulated device study