Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Hester Goddard
ORCID ID
Contact details
R&D Unit
Cardiothoracic BioIncubator (CTBI) Building
Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
+44 (0)1480 364181
hester.goddard@papworth.nhs.uk
Type
Scientific
Additional contact
Mr Sam Nashef
ORCID ID
Contact details
Department of Surgery
Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 07/01/34
Study information
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
Acronym
AMAZE
Study hypothesis
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
Pending, to be submitted as of 04/04/2008
Study design
Multi-centre prospective randomised controlled 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 contact details to request a participant information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/09/2008
Overall trial end date
29/02/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant 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
Recruitment start date
01/09/2008
Recruitment end date
29/02/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Papworth Hospital NHS Foundation Trust
Cambridge
CB23 3RE
United Kingdom
Sponsor information
Organisation
Papworth Hospital NHS Foundation Trust (UK)
Sponsor details
c/o Dr Hester Goddard
R&D Unit
Cardiothoracic BioIncubator (CTBI) Building
Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
+44 (0)1480 364181
hester.goddard@papworth.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/07/2017
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary