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THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

NCT00530894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1057

Last updated 2017-09-13

Study results available
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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.

Conditions

  • Critical Aortic Stenosis

Interventions

DEVICE

Edwards SAPIEN Transcatheter Heart Valve

DEVICE

Surgical Valve Replacement

OTHER

medical management and/or balloon aortic valvuloplasty

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

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

  • Craig Smith, MD · New York-Presbyterian Hospital/Columbia University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-09-30
Completion
2017-07-31

Countries

  • United States
  • Canada
  • Germany

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 NCT00530894 on ClinicalTrials.gov