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 fibrillatio

Not Applicable

Completed

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

• Registration Number: ISRCTN82731440
• Lead Sponsor: Papworth Hospital NHS Foundation Trust (UK)

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29701167 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35348642/ five-year results (added 30/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-04
• Study Completion: 2012-02-29
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 352

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Patient benefit will be assessed by the following:<br> 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<br> 2. Quality-adjusted survival over 2 years<br>

Secondary Outcome Measures

Name	Time	Method
<br> The following will be assessed at 6, 12 and 24 months and annually thereafter, except where indicated otherwise:<br> 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.<br> 2. Other secondary objectives will be to determine whether the adjunct ablation device-based procedure:<br> 2.1. Improves the rate of return to stable SR at 24 months after surgery<br> 2.2. Improves atrial function (i.e. increases atrial transport ? assessed by echocardiography)<br> 2.3. Decreases thromboembolic neurological complications (e.g. stroke)<br> 2.4. Enables anticoagulant treatment to be withdrawn safely<br> 2.5. Enables safe reduction or withdrawal of antiarrhythmic medication<br>