Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alan Bryan

ORCID ID

Contact details

c/o Research and Development Office
Level 1
Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264073738

Study information

Scientific title

Acronym

Study hypothesis

Comparison of long-term clinical outcome with two bileaflet carbon prostheses.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Mechanical heart valve replacement

Intervention

Randomised prospective trial.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Death
2. Thromboembolic events
3. Bleeding
4. Valve dysfunction.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1993

Overall trial end date

01/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing mechanical heart valve replacement.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

485

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/07/1993

Recruitment end date

01/02/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o Research and Development Office
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

United Bristol Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11782752
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17320553

Publication citations

  1. Results

    Lim KH, Caputo M, Ascione R, Wild J, West R, Angelini GD, Bryan AJ, Prospective randomized comparison of CarboMedics and St Jude Medical bileaflet mechanical heart valve prostheses: an interim report., J. Thorac. Cardiovasc. Surg., 2002, 123, 1, 21-32.

  2. Results

    Bryan AJ, Rogers CA, Bayliss K, Wild J, Angelini GD, Prospective randomized comparison of CarboMedics and St. Jude Medical bileaflet mechanical heart valve prostheses: ten-year follow-up., J. Thorac. Cardiovasc. Surg., 2007, 133, 3, 614-622, doi: 10.1016/j.jtcvs.2006.08.075.

Additional files

Editorial Notes