Partner 3 (P3E)

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement Who Have Severe, Calcific, Symptomatic Aortic Stenosis

Partner 3 (P3E) [NCT02675114]

Description: To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, symptomatic aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

Procedure: Surgical aortic valve replacement (SAVR); Device: Transcatheter Aortic Valve Replacement (TAVR)

Primary Investigator: Kereiakes

Drug/Device Information
To establish the safety and effectiveness of the Sapien 3 transcatheter heart valve in low risk patients requiring aortic valve replacement
Edwards Sapien 3 THV system model 9600 TFX
Sizes 20, 23, 26 and 29mm
Randomized 1:1 to Sapien 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve
Edwards Lifesciences LLC