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

ISRCTN	ISRCTN56511757
DOI	https://doi.org/10.1186/ISRCTN56511757
Protocol serial number	P00715
Sponsor	Papworth Hospital NHS Trust (UK)
Funder	Edwards LifeSciences Ltd (UK) - Industrial grant

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Steven Tsui
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To 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) studied	Aortic valve replacement
Intervention	Prima Plus (Edwards Lifesciences) stentless bioprosthesis or the Carpentier-Edwards Perimount stented bioprosthesis (Edwards Lifesciences).
Intervention type	Other
Primary outcome measure(s)	Post-operative pressure gradient across the prosthetic valve and effective valve orifice area.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	05/07/2005

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	240
Key inclusion criteria	Inclusion 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 criteria	1. 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 enrolment	01/03/2001
Date of final enrolment	05/07/2005

Surgical Unit

Papworth Everard
CB3 8RE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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