NCT01503268

Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders: The ACTUAL Study

Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eastbourne General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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.
PROCEDURE	Percutaneous ablation of atrial fibrillation	Catheter-based percutaneous ablation of atrial fibrillation
PROCEDURE	Surgical ablation of atrial fibrillation	Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2012-01-04
• Last updated: 2013-06-21

Locations

2 sites across 1 country: United Kingdom