Condition category
Circulatory System
Date applied
17/02/2010
Date assigned
25/03/2010
Last edited
02/09/2010
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

Prof Magdi Yacoub

ORCID ID

Contact details

Harefield Heart Science Centre
Hill End Road
Harefield
UB9 6JH
United Kingdom
m.yacoub@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A prospective randomised trial comparing autograft versus homograft aortic root replacement

Acronym

Study hypothesis

Homografts and autografts have been used for many years with good clinical and haemodynamic results. In contrast to homografts, autografts are the only valve substitutes which ensure long-term viability of the aortic valve. We believe that this translates into clinically relevant endpoints following aortic root replacement.

Ethics approval

Hillingdon Health Authority approved on the 12th January 1994

Study design

Single centre prospective randomised comparison trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Aortic valve disease

Intervention

Two interventions will be compared:
1. Homograft aortic root replacement with coronary reimplantation
2. Autograft aortic root replacement with coronary reimplantation and replacement of the pulmonary root with a homograft

The operations will be carried out by a single surgeon (Sir Magdi Yacoub). The surgical techniques are well established and have been previously published.

Patients will be followed at 1 month, 6 months, 1 year and yearly thereafter with outpatient clinic appointments and echocardiographic evaluation. In patients with normal and stable echocardiographic results and no functional limitation, the follow-up will be extended to every 2 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Survival at 10 years

Secondary outcome measures

1. Incidence of the need for reoperation
2. Quality of life (QOL): assessed using the 36-item Short Form health survey (SF-36) quality of life standardised questionnaire, which will be sent by mail with a return envelope to all patients
3. Incidence of valve-related complications: endocarditis, major bleeding, thrombosis or thromboembolism
4. Specific echocardiographic parameters:
4.1. Progression of transaortic pressure gradient
4.2. Progression in the degree of aortic regurgitation and incidence of aortic regurgitation grade 3+ and 4+
4.3. Changes in aortic root diameter measured at the sinuses of Valsalva and incidence of aortic root dilatation greater than 45 mm
4.4. Changes in left ventricular end-diastolic and end-systolic diameters
4.5. Changes in ejection fraction
4.6. Progression of transpulmonary gradient through the homograft in the autograft group

Overall trial start date

15/05/1994

Overall trial end date

15/11/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with symptomatic aortic valve disease requiring aortic valve replacement
2. Patients with concomitant aortic root dilatation and/or ascending aortic dilatation and aortic valve dysfunction requiring surgery
3. Patients with bicuspid aortic valve disease requiring aortic valve replacement
4. Patients with aortic valve endocarditis
5. Patients who have undergone previous cardiac surgery
6. Aged less than 69 years, either sex
7. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

216

Participant exclusion criteria

1. Marfan syndrome
2. Reither's syndrome
3. Rheumatoid arthritis
4. Aged less than 5 years or greater than 69 years
5. Inability to consent
6. Other known disease potentially shortening life expectancy to less than 15 years
7. When completeness of follow-up is judged unlikely by the investigators

Recruitment start date

15/05/1994

Recruitment end date

15/11/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Harefield Heart Science Centre
Harefield
UB9 6JH
United Kingdom

Sponsor information

Organisation

Royal Brompton and Harefield NHS Foundation Trust (UK)

Sponsor details

Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom
m.yacoub@imperial.ac.uk

Sponsor type

Government

Website

http://www.rbht.nhs.uk/

Funders

Funder type

Charity

Funder name

The Magdi Yacoub Institute (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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20684981

Publication citations

  1. Results

    El-Hamamsy I, Eryigit Z, Stevens LM, Sarang Z, George R, Clark L, Melina G, Takkenberg JJ, Yacoub MH, Long-term outcomes after autograft versus homograft aortic root replacement in adults with aortic valve disease: a randomised controlled trial., Lancet, 2010, 376, 9740, 524-531, doi: 10.1016/S0140-6736(10)60828-8.

Additional files

Editorial Notes