Hybrid AbLaTion of Atrial Fibrillation - HALT AF
Research type
Research Study
Full title
A Study to Assess Hybrid Ablation of Atrial Fibrillation (HALT-AF)
IRAS ID
291145
Contact name
Riyaz Kaba
Contact email
Sponsor organisation
St Georges University of London
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Atrial fibrillation (AF) is the commonest heart rhythm disturbance worldwide, affecting 2-4% of adults and over 10% of those aged ≥75. It is a major preventable cause of stroke, heart failure and dementia and is characterised by an irregularly irregular pulse and loss of coordinated heart function. In 2010, 700,000 patients had AF, and Public Health England estimates it affected 1.49 million in 2019. Prevalence is increasing despite medical advances due to an ageing population and increasing survival of patients with cardiovascular comorbidities like hypertension and heart failure.
AF usually begins intermittently (paroxysmal); however, it can become established (persistent) with time. This is the fastest-growing demographic. AF poses significant therapeutic challenges: Symptoms range from mild to severe, may vary over time and be entirely debilitating. It carries a significant socioeconomic burden: Admissions have increased 60% in 20 years. Direct costs rose from £459m in 2000 to £1,435-£2548m in 2020. Forecasts suggest this trend will continue over the next two decades, and AF will directly account for 1.35-4.27% of NHS expenditure, predominantly driven by hospitalisation costs.
Restoration of normal rhythm is possible and improves symptoms and reduces life-threatening consequences and hospitalisations. However, long-term outcomes using medications or electrical shock are poor, with considerable relapse rates, side effects, and risks. The advancement in non-pharmacological therapies such as catheter and surgical ablation has had success in treating paroxysmal AF. However, the best treatment for persistent AF remains to be defined, with current therapies proving sub-optimal. Our proposed rigorously designed and conducted randomised trial will comprehensively assess a new treatment: Convergent hybrid ablation, which has shown encouraging outcomes in the available literature and our pilot study. It will determine procedural success rates, the effect on symptoms and quality of life, and relative morbidity compared to the current standard of care provided, namely catheter ablation.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
21/SW/0082
Date of REC Opinion
7 Jul 2021
REC opinion
Further Information Favourable Opinion