Comparison of outcomes following aortic valve replacement with two different types of valve substitutes

ISRCTN	ISRCTN03530985
DOI	https://doi.org/10.1186/ISRCTN03530985
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	N/A
Sponsor	Royal Brompton and Harefield NHS Foundation Trust (UK)
Funder	The Magdi Yacoub Institute (UK)

Submission date: 17/02/2010
Registration date: 25/03/2010
Last edited: 09/11/2023

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

Prof Magdi Yacoub
Scientific

Harefield Heart Science Centre
Hill End Road
Harefield
UB9 6JH
United Kingdom

Email	m.yacoub@imperial.ac.uk

Study information

Primary study design	Interventional
Study design	Single-centre prospective randomized comparison trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A prospective randomised trial comparing autograft versus homograft aortic root replacement
Study objectives	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(s)	Hillingdon Health Authority approved on the 12th January 1994
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Survival at 10 years
Key secondary outcome measure(s)	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
Completion date	15/11/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	5 Years
Upper age limit	69 Years
Sex	All
Target sample size at registration	216
Total final enrolment	228
Key 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
Key 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
Date of first enrolment	15/05/1994
Date of final enrolment	15/11/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Harefield Heart Science Centre

Harefield
UB9 6JH
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		14/08/2010		Yes	No
Other publications	Post hoc analysis	08/11/2023	09/11/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/11/2023: Publication reference and total final enrolment added.