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Completed

NCT Number: NCT00639782

Prospective Randomized On-X Versus SJM Evaluation Trial

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

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Key information

Conditions

Heart Valve Disease Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Heart Valve Diseases Thromboembolism Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

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About this study

The study is a multi-centre, randomized trial that will sequentially enroll up to 500 eligible patients in each group from up to 10 participating study centres internationally to test the hypothesis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient requires an isolated mitral or isolated aortic valve replacement. (Patients undergoing coronary artery bypass and / or concomitant repair of mitral or tricuspid valves are eligible.)
  • The patient is a candidate for receipt of a mechanical heart valve.
  • The patient (or legal guardian) has signed a study-specific informed consent form agreeing to the randomization, data collection and follow-up requirements.
  • The patient can be having a re-operative procedure, so long as the previous prosthetic valve is explanted and the patient does not become a double valve implantation patient.

Exclusion criteria

  • The patient is not a candidate to receive a mechanical heart valve.
  • The patient already has a prosthetic valve other than the valve(s) being replaced at this time.
  • The patient requires a tricuspid valve replacement.
  • The patient is enrolled in another investigative study or trial.

Treatment and study plan

On-X Heart valve replacement

Device

On-X Heart valve replacement

Other names: On-X Prosthetic Heart Valve

SJM Heart valve replacement

Device

SJM Heart valve replacement

Other names: St. Jude Medical Prosthetic Heart Valve

Primary outcomes

  1. Thromboembolisms

    Time frame: 5 years

    Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.

Sponsors and collaborators

Lead sponsor

On-X Life Technologies, Inc.

Industry

Registry information

Official study title

Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses

Acronym: PROSE

Important dates

Study start
2003
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2008
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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