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

Conditions

Patients with pre-existing atrial fibrillation (AF) requiring elective cardiac surgery Circulatory System Atrial fibrillation and flutter

Linda Sharples, C Mills, Yi‐Da Chiu, Simon P. Fynn, H. Holcombe et al. (6 authors)

European Journal of Cardio-Thoracic Surgery2022-03-2311 citations

10.1093/ejcts/ezac181

Amaze: a double-blind, multicentre randomised controlled trial to investigate the clinical effectiveness and cost-effectiveness of adding an ablation device-based maze procedure as an adjunct to routine cardiac surgery for patients with pre-existing atrial fibrillation.

Sharples L, Everett C, Singh J, Mills C, Spyt T, Abu-Omar Y, Fynn S, Thorpe B, Stoneman V, Goddard H, Fox-Rushby J, Nashef S.

2018-04-0113 citations

10.3310/hta22190

Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation†

Samer A.M. Nashef, Simon P. Fynn, Yasir Abu-Omar, Tomasz Spyt, C Mills et al. (14 authors)

European Journal of Cardio-Thoracic Surgery2018-03-2820 citations

10.1093/ejcts/ezy165

Interventions

Elective cardiac surgery with or without addition of ablation device-based maze procedure as adjunct.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, United Kingdom

Outcome results

None listed