CLIP-AF
Research type
Research Study
Full title
Convergent ablation plus Left atrial appendage Isolation for the treatment of Persistent Atrial Fibrillation
IRAS ID
320553
Contact name
Syed Ahsan
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Over the last few decades, atrial fibrillation (AF) has become one of the principal healthcare burdens in the UK. AF is now the commonest sustained arrhythmia affecting 10% of people aged over 65 years old. With an ever ageing and increasing population, AF will remain a significant health issue in the future. Atrial Fibrillation is a major cause of morbidity and mortality, being a causative mechanism in ischaemic strokes and compounding heart failure.
The gold standard treatment for AF is catheter ablation. Triggers in pulmonary veins are treated with pulmonary vein isolation – this offers high success rates in paroxysmal AF. However, in persistent long standing AF (>1 year duration), outcomes are reported as moderate with 40-50% success. It is theorised that extrapulmonary vein triggers such as foci in the posterior wall of the left atrium, are key in initiating and maintaining persistent longstanding AF.
The Convergent procedure was developed to address this. This is a two stage hybrid procedure. The first stage is a surgical ablation involving creating a subxyphoid window for epicardial ablation of the posterior wall, at this point an AtriClip device may be Inserted. Then endocardial catheter ablation is performed 6 weeks later. A pilot study in 2020 showed superiority of this approach over catheter ablation alone. The Convergent procedure group had a significantly higher AF-free survival after 12 months on antiarrhythmic drugs (AADs) (60.5 % versus 25.6%, p=0.002) and off AADs (37.2% versus 13.9%, p=0.025), versus catheter ablation. Multivariate analysis identified only the convergent procedure as predictive of arrhythmia free survival long term(p=0.017).AtriClip exclusion of the left atrial appendage has shown to be a viable alternative to anticoagulation for stroke risk reduction.
This feasibility study would assess the Convergent procedure, in combination with the AtriClip device which has not been included in trial studies previously.REC name
South East Scotland REC 01
REC reference
24/SS/0026
Date of REC Opinion
2 May 2024
REC opinion
Further Information Favourable Opinion