NCT05172973

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Detailed description

Prospective, single arm, multicenter study

Conditions

• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	SAPIEN X4 THV	Implantation of the SAPIEN X4 valve

Timeline

• Start date: 2023-11-22
• Primary completion: 2026-12-01
• Completion: 2036-02-01
• First posted: 2021-12-29
• Last updated: 2025-12-22

Locations

35 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study