Condition category
Circulatory System
Date applied
16/05/2005
Date assigned
08/07/2005
Last edited
04/10/2007
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

Mr Steven Tsui

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P00715

Study information

Scientific title

Acronym

Study hypothesis

To find out which prosthetic valves represent the better option for patients requiring AVR.

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

Aortic valve replacement

Intervention

Prima Plus (Edwards Lifesciences) stentless bioprosthesis or the Carpentier-Edwards Perimount stented bioprosthesis (Edwards Lifesciences).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Post-operative pressure gradient across the prosthetic valve and effective valve orifice area.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/03/2001

Overall trial end date

05/07/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

240

Participant 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

Recruitment start date

01/03/2001

Recruitment end date

05/07/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Surgical Unit
Papworth Everard
CB3 8RE
United Kingdom

Sponsor information

Organisation

Papworth Hospital NHS Trust (UK)

Sponsor details

Surgical Unit
Papworth Everard
CB3 8RE
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Edwards LifeSciences Ltd (UK) - Industrial grant

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17532416

Publication citations

  1. Results

    Ali A, Halstead JC, Cafferty F, Sharples L, Rose F, Lee E, Rusk R, Dunning J, Argano V, Tsui S, Early clinical and hemodynamic outcomes after stented and stentless aortic valve replacement: results from a randomized controlled trial., Ann. Thorac. Surg., 2007, 83, 6, 2162-2168, doi: 10.1016/j.athoracsur.2007.01.021.

Additional files

Editorial Notes