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

Eastbourne General Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Atrial Fibrillation

Treatments: Device: Implantation of implantable loop recorder; Procedure: Surgical ablation of atrial fibrillation; Procedure: Percutaneous ablation of atrial fibrillation

Study type: Interventional

Funder types: Other

Identifiers

NCT01503268

ACTUAL 1.0

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Percutaneous ablation

Active Comparator group

Treatment:

Device: Implantation of implantable loop recorder

Procedure: Percutaneous ablation of atrial fibrillation

Surgical ablation

Active Comparator group

Treatment:

Device: Implantation of implantable loop recorder

Procedure: Surgical ablation of atrial fibrillation

DCCV

Active Comparator group

Description:

Direct current cardioversion

Treatment:

Device: Implantation of implantable loop recorder