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

NCT01503268 | Withdrawn Phase 4 DMC

• 1 other identifier: ACTUAL 1.0
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

Atrial fibrillation; Ablation; Percutaneous ablation; Minimally-invasive thoracoscopic ablation; Implantable loop recorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Time to recurrence of atrial fibrillation after ablation

  One year

• Time to recurrence of symptomatic atrial fibrillation after ablation

  One year

• New MRI-detected subclinical cerebral ischaemia

  1 year

Study Arms (3)

Percutaneous ablation

ACTIVE COMPARATOR

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

Surgical ablation

ACTIVE COMPARATOR

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

DCCV

ACTIVE COMPARATOR

Direct current cardioversion

Device: Implantation of implantable loop recorder

Interventions

Implantation of implantable loop recorder 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.

DCCV; Percutaneous ablation; Surgical ablation

Percutaneous ablation of atrial fibrillation PROCEDURE

Catheter-based percutaneous ablation of atrial fibrillation

Percutaneous ablation

Surgical ablation of atrial fibrillation PROCEDURE

Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation

Surgical ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic persistent atrial fibrillation
• Age over 18 years
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastbourne General Hospital: lead

Study Sites (2)

Royal Sussex County Hospital

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

Eastbourne District General Hospital

Eastbourne, East Sussex, BN21 2UD, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• A N Sulke, MD

  Eastbourne General Hospital

  PRINCIPAL INVESTIGATOR

• S S Furniss, MD

  Eastbourne General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: December 30, 2011
• First Posted: January 4, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

GB (2)