Prospective randomised trial of stented versus stentless bioprosthesis for aortic valve replacement (AVR)

ISRCTN ISRCTN56511757
DOI https://doi.org/10.1186/ISRCTN56511757
Secondary identifying numbers P00715
Submission date
16/05/2005
Registration date
08/07/2005
Last edited
04/10/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Steven Tsui
Scientific

Surgical Unit
Papworth Hospital NHS Trust
Papworth Everard
CB3 8RE
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo find out which prosthetic valves represent the better option for patients requiring AVR.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAortic valve replacement
InterventionPrima Plus (Edwards Lifesciences) stentless bioprosthesis or the Carpentier-Edwards Perimount stented bioprosthesis (Edwards Lifesciences).
Intervention typeOther
Primary outcome measurePost-operative pressure gradient across the prosthetic valve and effective valve orifice area.
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/03/2001
Completion date05/07/2005

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants240
Key inclusion criteriaInclusion criteria:
1. Patients who require elective AVR with a tissue valve for symptomatic aortic valve stenosis (peak valve gradient equal to or greater than 50 mmHg as measured by echocardiography), with or without concomitant artery bypass grafting
2. Patients = 65 years of age at the time of surgery
Key exclusion criteria1. Patients who are already enrolled in another major cardiovascular trial
2. AVR performed primarily for aortic valve regurgitation
3. Active aortic valve infection
4. Active malignant disease
5. Renal failure requiring dialysis
6. Any previous cardiac surgery
7. The need for additional cardiac procedures other than coronary artery bypass grafting
8. Emergency operations
9. Patients unable to give informed consent
Date of first enrolment01/03/2001
Date of final enrolment05/07/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Surgical Unit
Papworth Everard
CB3 8RE
United Kingdom

Sponsor information

Papworth Hospital NHS Trust (UK)
Hospital/treatment centre

Surgical Unit
Papworth Everard
CB3 8RE
England
United Kingdom

ROR logo "ROR" https://ror.org/01qbebb31

Funders

Funder type

Industry

Edwards LifeSciences Ltd (UK) - Industrial grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/06/2007 Yes No