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
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
-
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.
-
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.