A randomised controlled trial to investigate the clinical and cost effectiveness of adding an ablation device-based maze procedure as a routine adjunct to elective cardiac surgery for patients with pre-existing atrial fibrillation
| ISRCTN | ISRCTN82731440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82731440 |
| Secondary identifying numbers | HTA 07/01/34 |
- Submission date
- 04/04/2008
- Registration date
- 04/04/2008
- Last edited
- 30/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Atrial fibrillation (AF) is a fast irregular heart beat caused by abnormal electrical signalling. It is very common (affecting 1 in 20 middle aged people and 1 in 10 aged over 80) and the high risk of clotting leads to stroke in 1 in 25 AF patients if left untreated. AF patients are therefore given blood thinning drugs. These reduce strokes by about two thirds but can cause bleeding so patients need careful monitoring. In short, the complications and treatment of AF all reduce the patient's quality of life and are very costly for the NHS. The 'maze' procedure is major surgery which involves cutting and stitching the atrial wall to re-direct electrical signals down the correct paths. It can stop AF but is not widely used due to its complexity. However, ablation devices are now available that can be used to make a 'maze' procedure simpler, quicker and safer. The marketing of these devices claims that they can restore normal heart rhythm when incorporated into a routine heart operation. However, this needs evaluation before the technology creeps into practice. The aim of this study is to find out whether adding this costly technology to routine heart surgery is worthwhile for the patients and for the NHS.
Who can participate?
Patients aged over 18 with atrial fibrillation who are undergoing elective heart surgery
What does the study involve?
Participants are randomly allocated to undergo heart surgery either with or without the ablation device-based maze procedure. Survival, quality of life and cost effectiveness are compared between the two groups.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Papworth Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2008 to February 2012
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
Dr Hester Goddard
hester.goddard@papworth.nhs.uk
Contact information
Scientific
R&D Unit
Cardiothoracic BioIncubator (CTBI) Building
Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
| Phone | +44 (0)1480 364181 |
|---|---|
| hester.goddard@papworth.nhs.uk |
Scientific
Department of Surgery
Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
Study information
| Study design | Multi-centre prospective randomised controlled 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 contact details to request a participant information sheet |
| Scientific title | A randomised controlled trial to investigate the clinical and cost effectiveness of adding an ablation device-based maze procedure as a routine adjunct to elective cardiac surgery for patients with pre-existing atrial fibrillation |
| Study acronym | AMAZE |
| Study objectives | Treating a patient's atrial fibrillation (AF) by incorporating a modified maze procedure (using an AF ablation device) into their elective cardiac surgery will improve their quality of life as well as being cost effective from an NHS perspective. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/070134 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0020/51716/PRO-07-01-34.pdf |
| Ethics approval(s) | Pending, to be submitted as of 04/04/2008 |
| Health condition(s) or problem(s) studied | Patients with pre-existing atrial fibrillation (AF) requiring elective cardiac surgery |
| Intervention | Elective cardiac surgery with or without addition of ablation device-based maze procedure as adjunct. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Patient benefit will be assessed by the following: 1. Rate of return to stable sinus rhythm (SR) at 12 months. Seven-day electrocardiogram (ECG) monitors will be used to assess the predominant rhythm (SR or AF) and the AF load i.e. the percentage of time that the patient is in AF if their predominant rhythm is SR 2. Quality-adjusted survival over 2 years |
| Secondary outcome measures | The following will be assessed at 6, 12 and 24 months and annually thereafter, except where indicated otherwise: 1. Cost-effectiveness for the NHS will be assessed by collecting resource use data and costs incurred by both groups and comparing their costs per quality-adjusted life year (QALY). Further longer term economic modelling will also be undertaken. 2. Other secondary objectives will be to determine whether the adjunct ablation device-based procedure: 2.1. Improves the rate of return to stable SR at 24 months after surgery 2.2. Improves atrial function (i.e. increases atrial transport assessed by echocardiography) 2.3. Decreases thromboembolic neurological complications (e.g. stroke) 2.4. Enables anticoagulant treatment to be withdrawn safely 2.5. Enables safe reduction or withdrawal of antiarrhythmic medication |
| Overall study start date | 01/09/2008 |
| Completion date | 29/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 352 |
| Key inclusion criteria | 1. Age over 18, both males and females 2. Patients will have elective cardiac surgery planned (coronary surgery, valve surgery, combined coronary and valve surgery, any other cardiac surgery requiring cardiopulmonary bypass) 3. Patients will have a history of documented atrial fibrillation (chronic, persistent or paroxysmal) beginning more than 3 months before entry into the study 4. All patients will provide written informed consent to participation |
| Key exclusion criteria | 1. Patients with previous cardiac operations 2. Patients having emergency or salvage cardiac operations 3. Patients whose surgery will not involve cardiopulmonary bypass 4. Patients who are unlikely to be available for follow-up over a two-year period 5. Patients who are deemed not competent to provide consent |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 29/02/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CB23 3RE
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Dr Hester Goddard
R&D Unit
Cardiothoracic BioIncubator (CTBI) Building
Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
England
United Kingdom
| Phone | +44 (0)1480 364181 |
|---|---|
| hester.goddard@papworth.nhs.uk | |
| Website | http://www.papworthhospital.nhs.uk |
"ROR" |
https://ror.org/01qbebb31 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2017 |
|---|---|
| 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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2018 | Yes | No | |
| Results article | five-year results | 26/03/2022 | 30/03/2022 | Yes | No |
Editorial Notes
30/03/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
30/04/2018: Publication reference added.
26/05/2016: Plain English summary added.
