Prospective Randomized On-X Versus SJM Evaluation Trial (PROSE)

May 23, 2021 updated by: On-X Life Technologies, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

857

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Royal Prince Alfred Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • St. Paul's Hospital
      • Victoria, British Columbia, Canada, V8R 4R2
        • Victoria Heart Institute
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Horizon New Brunswick Heart Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • Germany
      • Freiburg, Germany, 79106
        • Universitäts-Herzzentrum Bad Krozingen
      • Freiburg, Germany, 79106
        • Universitats-Herzzentrum Freiburg - Medical Center
      • Jena, Germany, 7743
        • Universitats Klinik Jena
      • Tübingen, Germany, 72074
        • Universitat Klinik Tubingen
  • India
    • Gujarat
      • Sūrat, Gujarat, India, 395 001
        • Sri Bachubahi Dayabhai Mehta Mahavir Heart Institute
    • Karnataka
      • Bangalore, Karnataka, India, 560 069
        • Shri Jaya Deva Institute of Cardiovascular Sciences
    • Punjab
      • Ludhiāna, Punjab, India, 141 001
        • Hero Dayanand Medical College and Hospitals
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 006
        • Apollo Hospital Chennai
      • Chennai, Tamil Nadu, India, 600 101
        • Frontier lifeline Hospital
      • Madurai, Tamil Nadu, India, 625 020
        • Apollo Multispecialty Hospitals
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221 005
        • Banaras Hindu University
  • Netherlands
      • Rotterdam, Netherlands, 3000 CA
        • Erasmus Medical Center
  • Norway
      • Bergen, Norway, N-5021
        • University of Bergen
  • South Africa
      • Cape Town, South Africa, 7935
        • Groote Schuur Hospital
  • Sweden
      • Gothenburg, Sweden, SE41345
        • Sahlgrenska University Hospital
  • United States
    • California
      • Los Angeles, California, United States, 91101
        • Southern California Permanente Medical Group
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Kaiser Foundation Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University - St Louis
      • Saint Louis, Missouri, United States, 63136
        • Christian Hospital Northeast
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Robert Wood Johnson Medical School
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.)
  2. The patient is a candidate for receipt of a mechanical heart valve.
  3. The patient (or legal guardian) has signed a study-specific informed consent form agreeing to the randomization, data collection and follow-up requirements.
  4. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ONX
On-X heart Valve Replacement
Device: On-X Heart valve replacement
On-X Heart valve replacement
Other Names:
  • On-X Prosthetic Heart Valve
Active Comparator: SJM
SJM heart valve replacement
Device: SJM Heart valve replacement
SJM Heart valve replacement
Other Names:
  • St. Jude Medical Prosthetic Heart Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thromboembolisms
Time Frame: 5 years
Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

On-X Life Technologies, Inc.

Investigators

  • Principal Investigator: Eric Jamieson, MD, Vancouver Coastal Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

February 16, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 23, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONXSJM1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Valve Disease

Clinical Trials on On-X Heart valve replacement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe