A Phase 4 interventional study of Implantation of implantable loop recorder and Percutaneous ablation of atrial fibrillation in Atrial Fibrillation, sponsored by Eastbourne General Hospital. Withdrawn at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-21.
Sponsored by Eastbourne General Hospital · Phase 4, Interventional, and Treatment
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
Browse Atrial Fibrillation studies →Eastbourne General Hospital is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Implantation of implantable loop recorder · Procedure: Percutaneous ablation of atrial fibrillation
Device: Implantation of implantable loop recorder · Procedure: Surgical ablation of atrial fibrillation
Direct current cardioversion
Device: Implantation 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.
Catheter-based percutaneous ablation of atrial fibrillation
Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation
Reduction in AF burden after ablation
Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder
Time frame: One year
Time to recurrence of persistent AF
Time frame: 1 year
Time to recurrence of atrial fibrillation after ablation
Time to first detected episode of atrial fibrillation after ablation, outside a 3 month blanking period
Time frame: One year
Time to recurrence of symptomatic atrial fibrillation after ablation
Time to first detected symptomatic episode of atrial fibrillation after ablation, outside a 3 month blanking period
Time frame: One year
New MRI-detected subclinical cerebral ischaemia
Time frame: 1 year
This study is withdrawn, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Eastbourne General Hospital