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

NCT ID: NCT01503268

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-11-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous ablation

Group Type: ACTIVE_COMPARATOR

Implantation of implantable loop recorder

Intervention Type: DEVICE

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.

Percutaneous ablation of atrial fibrillation

Intervention Type: PROCEDURE

Catheter-based percutaneous ablation of atrial fibrillation

Surgical ablation

Group Type: ACTIVE_COMPARATOR

Implantation of implantable loop recorder

Intervention Type: DEVICE

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.

Surgical ablation of atrial fibrillation

Intervention Type: PROCEDURE

Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation

DCCV

Direct current cardioversion

Group Type: ACTIVE_COMPARATOR

Implantation of implantable loop recorder

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Percutaneous ablation of atrial fibrillation

Catheter-based percutaneous ablation of atrial fibrillation

Intervention Type: PROCEDURE

Surgical ablation of atrial fibrillation

Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastbourne General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Neil Sulke

Consultant Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

A N Sulke, MD

Role: PRINCIPAL_INVESTIGATOR

Eastbourne General Hospital

S S Furniss, MD

Role: PRINCIPAL_INVESTIGATOR

Eastbourne General Hospital

Locations

Royal Sussex County Hospital

Brighton, East Sussex, United Kingdom

Eastbourne District General Hospital

Eastbourne, East Sussex, United Kingdom

Countries

United Kingdom

Other Identifiers

ACTUAL 1.0

Identifier Type: -

Identifier Source: org_study_id