Clincosm LogoSign in Get a demo

PROSE: Prospective Randomized On-X Versus SJM Evaluation Trial

Sponsor
On-X Life Technologies, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00639782
Collaborator
(none)
857
Enrollment
28
Locations
2
Arms
214
Duration (Months)
30.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: On-X Heart valve replacement
  • Device: SJM Heart valve replacement
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
857 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses
Study Start Date :
Jul 1, 2003
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Thromboembolisms [5 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • On-X Life Technologies, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    On-X Life Technologies, Inc.
    ClinicalTrials.gov Identifier:
    NCT00639782
    Other Study ID Numbers:
    • ONXSJM1
    First Posted:
    Mar 20, 2008
    Last Update Posted:
    May 25, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by On-X Life Technologies, Inc.
    thromboembolism
    mechanical heart valves
    randomized
    Additional relevant MeSH terms:
    Heart Valve Diseases

    Study Results

    No Results Posted as of May 25, 2021