Cardiovascular Atlas
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PARTNER 3 trial

A trial that compared TAVR (with the SAPIEN 3 valve) against open-heart surgery in 1000 people with severe aortic stenosis who were at low risk from surgery. After one year, fewer people in the TAVR group had died, had a stroke or had gone back to hospital. It was paid for by Edwards Lifesciences, the FDA applicant for the valve, and the registry lists no masking.

Also called PARTNER 3 · P3 · PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group, open-label trial of TAVR with a balloon-expandable valve versus surgical aortic valve replacement. The registry records allocation as randomized, intervention model as parallel and masking as none.
Phase
Not applicable
Enrolled
  • 1,000 participants (enrolled count) (PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis, retrieved )
  • 1,000 patients (randomized count) (Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients, retrieved )
Sponsor
Funder
Registry
  • NCT NCT02675114
Started
(actual) (PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis, retrieved )
Primary completion
(actual) (PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis, retrieved )
Completion
(anticipated) (PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis, retrieved )
Results first posted
(actual) (PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis, retrieved )
Countries
United States, Australia, Canada, Japan, New Zealand (PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis, retrieved )
Care setting
71 centers (abstract); the registry lists sites in five countries. (Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients, retrieved )
Registry status
  • “ACTIVE_NOT_RECRUITING” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Registry NCT02675114 (Edwards Lifesciences lead sponsor, class industry, status active but not recruiting, estimated completion 2029-12). Randomized, parallel, no masking, treatment. Abstract: noninferiority margin 6 percentage points, as-treated analysis; primary composite at 1 year 8.5% versus 15.1% (hazard ratio 0.54). Findings are not tabulated because the primary composite has no outcome record in this atlas.

Arms

  • TAVR with the SAPIEN 3 valve

    Intervention SAPIEN 3 transcatheter heart valve

    Transcatheter aortic valve replacement with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System (registry), placed through the femoral artery with a balloon-expandable valve (abstract).

  • Surgical aortic valve replacement

    Intervention Surgical aortic valve replacement

    Surgical aortic valve replacement with a commercially available bioprosthetic valve (registry).

Findings

No findings are published for this study.

Record details

Record id
cardio:partner-3
Content hash
6157e9923a24dd2b77c510bfe7f4a12012c69903bd9ee3c3c3eea55295613fc5