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

Primary Purpose

Heart Valve Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
On-X Heart valve replacement
SJM Heart valve replacement
Sponsored by
On-X Life Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Valve Disease focused on measuring thromboembolism, mechanical heart valves, randomized

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southern California Permanente Medical Group
  • Kaiser Foundation Hospital
  • Washington University - St Louis
  • Christian Hospital Northeast
  • Robert Wood Johnson Medical School
  • Hospital of the University of Pennsylvania
  • Sentara Norfolk General Hospital
  • Royal Prince Alfred Hospital
  • St. Paul's Hospital
  • Vancouver General Hospital
  • Victoria Heart Institute
  • Horizon New Brunswick Heart Centre
  • Jewish General Hospital
  • Universitats-Herzzentrum Bad Krozingen
  • Universitats-Herzzentrum Freiburg - Medical Center
  • Universitats Klinik Jena
  • Universitat Klinik Tübingen
  • Sri Bachubahi Dayabhai Mehta Mahavir Heart Institute
  • Shri Jaya Deva Institute of Cardiovascular Sciences
  • Hero Dayanand Medical College and Hospitals
  • Apollo Hospital Chennai
  • Frontier Lifeline Hospital
  • Apollo Multispecialty Hospitals
  • Banaras Hindu University
  • Erasmus Medical Center
  • University of Bergen
  • Groote Schuur Hospital
  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ONX

SJM

Arm Description

On-X heart Valve Replacement

SJM heart valve replacement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 16, 2008
Last Updated
May 23, 2021
Sponsor
On-X Life Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00639782
Brief Title
Prospective Randomized On-X Versus SJM Evaluation Trial
Acronym
PROSE
Official Title
Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
On-X Life Technologies, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Disease
Keywords
thromboembolism, mechanical heart valves, randomized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
857 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ONX
Arm Type
Active Comparator
Arm Description
On-X heart Valve Replacement
Arm Title
SJM
Arm Type
Active Comparator
Arm Description
SJM heart valve replacement
Intervention Type
Device
Intervention Name(s)
On-X Heart valve replacement
Other Intervention Name(s)
On-X Prosthetic Heart Valve
Intervention Description
On-X Heart valve replacement
Intervention Type
Device
Intervention Name(s)
SJM Heart valve replacement
Other Intervention Name(s)
St. Jude Medical Prosthetic Heart Valve
Intervention Description
SJM Heart valve replacement
Primary Outcome Measure Information:
Title
Thromboembolisms
Description
Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Jamieson, MD
Organizational Affiliation
Vancouver Coastal Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
91101
Country
United States
Facility Name
Kaiser Foundation Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Washington University - St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Christian Hospital Northeast
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Victoria Heart Institute
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Horizon New Brunswick Heart Centre
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Universitats-Herzzentrum Bad Krozingen
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitats-Herzzentrum Freiburg - Medical Center
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitats Klinik Jena
City
Jena
ZIP/Postal Code
7743
Country
Germany
Facility Name
Universitat Klinik Tübingen
City
Tübingen
ZIP/Postal Code
72074
Country
Germany
Facility Name
Sri Bachubahi Dayabhai Mehta Mahavir Heart Institute
City
Sūrat
State/Province
Gujarat
ZIP/Postal Code
395 001
Country
India
Facility Name
Shri Jaya Deva Institute of Cardiovascular Sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 069
Country
India
Facility Name
Hero Dayanand Medical College and Hospitals
City
Ludhiāna
State/Province
Punjab
ZIP/Postal Code
141 001
Country
India
Facility Name
Apollo Hospital Chennai
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 006
Country
India
Facility Name
Frontier Lifeline Hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 101
Country
India
Facility Name
Apollo Multispecialty Hospitals
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 020
Country
India
Facility Name
Banaras Hindu University
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221 005
Country
India
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
University of Bergen
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
Facility Name
Groote Schuur Hospital
City
Cape Town
ZIP/Postal Code
7935
Country
South Africa
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
SE41345
Country
Sweden

12. IPD Sharing Statement

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Prospective Randomized On-X Versus SJM Evaluation Trial

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