The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

  • STATUS
    Not Recruiting
  • End date
    Mar 4, 2027
  • participants needed
    1328
  • sponsor
    Edwards Lifesciences
Updated on 14 April 2021
aortic valve replacement
transcatheter aortic valve implantation
aortic valve calcification

Summary

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

Description

Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.

A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/QOL. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.

Details
Condition Aortic Stenosis
Treatment Surgical aortic valve replacement (SAVR), Transcatheter Aortic Valve Replacement (TAVR)
Clinical Study IdentifierNCT02675114
SponsorEdwards Lifesciences
Last Modified on14 April 2021

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