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Prospective Randomized On-X Versus SJM Evaluation Trial

NCT00639782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 857

Last updated 2021-05-25

No results posted yet for this study

Summary

The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.

Conditions

  • Heart Valve Disease

Interventions

DEVICE

On-X Heart valve replacement

On-X Heart valve replacement

DEVICE

SJM Heart valve replacement

SJM Heart valve replacement

Sponsors & Collaborators

  • On-X Life Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Jamieson, MD · Vancouver Coastal Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • India
  • Netherlands
  • Norway
  • South Africa
  • Sweden

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 NCT00639782 on ClinicalTrials.gov