Research with human participants

Overview of medical research in the Netherlands

PROSE: Prospective Randomized On-X / St. Jude Medical Evaluation

Published:
Last updated:

To investigate whether the incidence of major thromboembolic complications is reduced with On-X compared to St. Jude medical.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Cardiac valve disorders
Study type
Interventional

ID

NL-OMON39125

Source

ToetsingOnline

Brief title

PROSE study

Condition

  • Cardiac valve disorders
  • Cardiac therapeutic procedures

Synonym

Bloodclot complications, incidence of obstruction due to bloodclot.

Research involving

Human

Sponsors and support

Primary sponsor :
On-X Life Technologies, Inc
Source(s) of monetary or material Support :
On-X Life Technologies

Intervention

Keyword :
AVR, Mechanical Heart Valve, MVR

Outcome measures

Primary outcome

Incidence of major thromboembolic events during 5 year FU

Secondary outcome

_

Background summary

To investigate the incidence of longterm major thromboembolic complications
after hartvalve repalcement with a mechanical heart valve.

Study objective

To investigate whether the incidence of major thromboembolic complications is
reduced with On-X compared to St. Jude medical.

Study design

A Multi-centre randomized trial to sequentially enroll 250 eligible patients in
each group (500 total) from 10-15 participating centres in North America and
Europe. It is estimated that each centre will be able to randomize 30-40
patients. The final analysis will begin approximately one year after the final
patient has been enrolled, resulting in study comparison.

Intervention

Haert Valve replacement of the Mitral valve or Aortic valve with a mechanical
heart valve prothesis.

Study burden and risks

Standard risks for open heart surgery and heart valve replacement with a
mechanical heart valve.

Public
On-X Life Technologies, Inc

8200 Cameron Road Suite A-196
Austin Texas 78754-3832 78754-3832
US
Scientific
On-X Life Technologies, Inc

8200 Cameron Road Suite A-196
Austin Texas 78754-3832 78754-3832
US

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

1. Isolated mitral - or isolated aortic valve replacement (eligible for coronary artery bypass and / or concomitant repair of mitral of tricuspid valves)
2. Candidate for receipt of mechanical heart valve

Exclusion criteria

Patient is not a candidate to receive a mechanical heart valve
Double valve replacement
Patient requires tricuspid valve replacement
Enrollment in another investigative trial / study

Design

Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
30
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
Other GOV NCT 00639782
CCMO NL27949.078.09