Comparison of outcomes following aortic valve replacement with two different types of valve substitutes
| ISRCTN | ISRCTN03530985 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03530985 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Prof Magdi Yacoub
Scientific
Scientific
Harefield Heart Science Centre
Hill End Road
Harefield
UB9 6JH
United Kingdom
| m.yacoub@imperial.ac.uk |
Study information
| Study design | Single-centre prospective randomized comparison trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A prospective randomised trial comparing autograft versus homograft aortic root replacement |
| 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(s) | Hillingdon Health Authority approved on the 12th January 1994 |
| 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 |
| Primary outcome measure | 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 study start date | 15/05/1994 |
| Overall study end date | 15/11/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 5 Years |
| Upper age limit | 69 Years |
| Sex | Both |
| Target number of participants | 216 |
| Total final enrolment | 228 |
| 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 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
- England
- United Kingdom
Study participating centre
Harefield Heart Science Centre
Harefield
UB9 6JH
United Kingdom
UB9 6JH
United Kingdom
Sponsor information
Royal Brompton and Harefield NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Harefield Hospital
Hill End Road
Harefield
UB9 6JH
England
United Kingdom
| m.yacoub@imperial.ac.uk | |
| Website | http://www.rbht.nhs.uk/ |
"ROR" |
https://ror.org/02218z997 |
Funders
Funder type
Charity
The Magdi Yacoub Institute (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
09/11/2023: Publication reference and total final enrolment added.
