NCT07116551

Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Symptomatic Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Abbott BE TAVI System	Abbott BE TAVI System

Timeline

• Start date: 2025-10-30
• Primary completion: 2031-06-01
• Completion: 2031-06-01
• First posted: 2025-08-11
• Last updated: 2026-02-06

Locations

5 sites across 2 countries: United States, France

Regulatory

• FDA-regulated device study