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

Phase 4

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Device: Implantation of implantable loop recorder; Procedure: Percutaneous ablation of atrial fibrillation; Procedure: Surgical ablation of atrial fibrillation

• Registration Number: NCT01503268
• Lead Sponsor: Eastbourne General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-30
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-04
• Study Start: 2012-11
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-21
• Primary Completion: 2014-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous ablation	Implantation of implantable loop recorder	-
Percutaneous ablation	Percutaneous ablation of atrial fibrillation	-
Surgical ablation	Implantation of implantable loop recorder	-
Surgical ablation	Surgical ablation of atrial fibrillation	-
DCCV	Implantation of implantable loop recorder	Direct current cardioversion

Primary Outcome Measures

Name	Time	Method
Time to recurrence of persistent AF	1 year
Reduction in AF burden after ablation	One year	Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder

Secondary Outcome Measures

Name	Time	Method
New MRI-detected subclinical cerebral ischaemia	1 year
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

Trial Locations

Locations (2)

Royal Sussex County Hospital; 🇬🇧 Brighton, East Sussex, United Kingdom

Eastbourne District General Hospital; 🇬🇧 Eastbourne, East Sussex, United Kingdom