NCT00530894

THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,057 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.

Detailed description

Subjects will undergo a physical exam and screening tests will be performed to determine if they are either A) a patient with a high surgical risk or B) not a candidate for surgery. They will then be randomized (like the flip of a coin) to have the investigational device implanted or to receive the current surgical or medical management available.

Conditions

• Critical Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Edwards SAPIEN Transcatheter Heart Valve
DEVICE	Surgical Valve Replacement
OTHER	medical management and/or balloon aortic valvuloplasty

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-09-01
• Completion: 2017-07-01
• First posted: 2007-09-18
• Last updated: 2017-09-13
• Results posted: 2017-05-11

Locations

26 sites across 3 countries: United States, Canada, Germany