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

NCT02675114 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-01-14

Study results available
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Summary

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

Conditions

  • Aortic Stenosis

Interventions

PROCEDURE

SAVR

SAVR with a commercially available bioprosthetic valve.

DEVICE

SAPIEN 3 THV

TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Martin B Leon, MD, FACC · Columbia University Medical Center/ New York Presbyterian Hospital, NY

  • Michael J Mack, MD, FACC · The Heart Hospital Baylor Plano, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-11-16
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Japan
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02675114 on ClinicalTrials.gov