NCT03003299

PARTNER 3 Trial - Aortic Valve-in-Valve

A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Detailed description

This is a prospective, single-arm, multicenter study.

Conditions

• Aortic Stenosis
• Aortic Stenosis, Severe

Interventions

Type	Name	Description
DEVICE	Edwards SAPIEN 3/SAPIEN 3 Ultra THV	Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

Timeline

• Start date: 2017-01-05
• Primary completion: 2033-01-01
• Completion: 2038-04-01
• First posted: 2016-12-28
• Last updated: 2024-05-10

Locations

51 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study