Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Ablation, Percutaneous ablation, Minimally-invasive thoracoscopic ablation, Implantable loop recorder
Brief summary
Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with medications, but these are not always effective or tolerated. Ablation is a well-recognised technique that is recommended for those with symptomatic AF who have failed medical therapy. Ablation can be performed in a number of ways. In percutaneous ablation, ablation is performed via tiny punctures in the skin in the groin. In minimally-invasive thoracoscopic ablation, ablation is performed under general anaesthetic via very small incisions in the chest wall. Because AF can be intermittent, the only reliable way to look for it is with long-term ECG monitoring. A safe and practical way to do this is to use implantable loop recorders (ILRs). In this study, the investigators are trying to see if minimally-invasive thoracoscopic ablation is better than percutaneous ablation, and in turn if they are better than Direct current cardioversion (DCCV), using ILRs to monitor AF.
Interventions
DEVICEImplantation of implantable loop recorder
An implantable loop recorder (ILR) will be used to assess atrial fibrillation(AF) before and after DCCV or ablation, unless there is a pre-existing ILR or permanent pacemaker capable of continuous monitoring for occurrence of AF.
PROCEDUREPercutaneous ablation of atrial fibrillation
Catheter-based percutaneous ablation of atrial fibrillation
PROCEDURESurgical ablation of atrial fibrillation
Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation
Sponsors
Eastbourne General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic persistent atrial fibrillation * Age over 18 years * Informed consent
Exclusion criteria
* Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI safe. * Patients unable to undergo general anaesthesia for AF ablation. * Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery * Previous thoracic surgery * Participation in a conflicting study * Participants who are mentally incapacitated and cannot consent or comply with follow-up * Pregnancy * Other cardiac rhythm disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in AF burden after ablation | One year | Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder |
| Time to recurrence of persistent AF | 1 year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrence of atrial fibrillation after ablation | One year | Time to first detected episode of atrial fibrillation after ablation, outside a 3 month blanking period |
| Time to recurrence of symptomatic atrial fibrillation after ablation | One year | Time to first detected symptomatic episode of atrial fibrillation after ablation, outside a 3 month blanking period |
| New MRI-detected subclinical cerebral ischaemia | 1 year | — |
Countries
United Kingdom
Outcome results
None listed