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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Implantation of implantable loop recorder; Procedure: Percutaneous ablation of atrial fibrillation; Procedure: Surgical ablation of atrial fibrillation

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 5BE
      • Royal Sussex County Hospital
    • Eastbourne, East Sussex, United Kingdom, BN21 2UD
      • Eastbourne District General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Percutaneous ablation	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
ACTIVE_COMPARATOR: Surgical ablation	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: Surgical ablation of atrial fibrillation; Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation
ACTIVE_COMPARATOR: DCCV; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recurrence of atrial fibrillation after ablation	Time to first detected episode of atrial fibrillation after ablation, outside a 3 month blanking period	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	One year
New MRI-detected subclinical cerebral ischaemia		1 year

Collaborators and Investigators

• Sponsor: Eastbourne General Hospital
• Investigators: Principal Investigator: A N Sulke, MD, Eastbourne General Hospital; Principal Investigator: S S Furniss, MD, Eastbourne General Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ANTICIPATED): November 1, 2014
• Study Completion (ANTICIPATED): November 1, 2014

Study Registration Dates

• First Submitted: December 30, 2011
• First Submitted That Met QC Criteria: January 3, 2012
• First Posted (ESTIMATE): January 4, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 21, 2013
• Last Update Submitted That Met QC Criteria: June 19, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Ablation; Implantable loop recorder; Percutaneous ablation; Minimally-invasive thoracoscopic ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ACTUAL 1.0