Catheter Vs Thoracoscopic Surgical Ablation in LSPAF - Multicentre RCT
Catheter Versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation - Multicentre Randomised Control Trial
Royal Brompton and Harefield NHS Foundation Trust
Duration of Study in the UK
3 years, 11 months, 30 days
Atrial fibrillation (AF) is the commonest heart rhythm disturbance, affecting 1-2% of the population. Its prevalence increases with age, from 0.5% at 40-50 years to 5-15% at 80 years. With an ageing population, AF will affect an increasing proportion of the population. In the UK alone, NHS admissions have risen 60% over 20 years, with total cost to the NHS of £2.2bn a year, and projected to double by 2050.
AF is characterised by an irregularly irregular pulse, loss of atrial contractile function and attendant loss of active ventricular filling, and risk of thromboembolic stroke. In addition to prevention of stroke with anticoagulants, there are two principal therapeutic strategies for treatment of AF: rhythm control (to restore sinus rhythm) and rate control (to accept AF and simply control the ventricular rate). Rhythm control is preferred in symptomatic patients, especially younger, more active patients with symptoms despite adequate rate control. Traditionally, rhythm control is attempted with antiarrhythmic drugs (AADs) and DC cardioversion. Long-term efficacy is poor, and it is associated with drug side-effects and risk of proarrhythmia. Consequently, there has been an increasing impetus particularly over the last two decades to advance non-pharmacological approaches to AF management.
Clinically, AF is categorised into three types: paroxysmal AF (recurrent fibrillation that terminates spontaneously within 7 days), persistent AF (lasting longer than 7 days or successfully terminated before with cardioversion) and longstanding persistent AF (arrhythmia persisting for more than a year).
Interventional treatments (surgical or catheter) have evolved over the years and nowadays allow reliable clinical success in treating paroxysmal AF, albeit with repeat procedures necessary in a proportion of patients. The best interventional treatment for symptomatic, LSPAF is yet to be defined. The encouraging results achieved with thoracoscopic surgical ablation in several cohort studies in persistent AF and LSPAF are also echoed by our pilot study results. These warrant further investigation in a properly powered randomised controlled trial amongst patients with a single AF type (LSPAF) and employing uniform lesion sets. The proposed trial will resolve this question, determining single and multiple procedure success rates, as well as the relative morbidity associated with each technique, the effect on quality of life and the cost effectiveness, in a rigorously designed and conducted study.
South Central - Oxford A Research Ethics Committee
Date of REC Opinion
5 Mar 2015
Further Information Favourable Opinion