Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Locations
- 4
- Primary Endpoint
- Time to recurrence of persistent AF
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Time to recurrence of persistent AF
Time Frame: 1 year
Reduction in AF burden after ablation
Time Frame: One year
Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder
Secondary Outcomes
- New MRI-detected subclinical cerebral ischaemia(1 year)
- Time to recurrence of atrial fibrillation after ablation(One year)
- Time to recurrence of symptomatic atrial fibrillation after ablation(One year)
Investigators
Neil Sulke
Consultant Cardiologist
Eastbourne General Hospital