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

Atrial Fibrillation Clinical Trial

— ACTUAL  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01503268
• Other study ID #: ACTUAL 1.0
• Status: Withdrawn
• Phase: Phase 4
• First received: December 30, 2011
• Last updated: June 19, 2013
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: June 2013
• Source: Eastbourne General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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
• Surgical ablation of atrial fibrillation
Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation

Locations

Country	Name	City	State
United Kingdom	Royal Sussex County Hospital	Brighton	East Sussex
United Kingdom	Eastbourne District General Hospital	Eastbourne	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Eastbourne General Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in AF burden after ablation	Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder	One year	No
Primary	Time to recurrence of persistent AF		1 year	No
Secondary	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	No
Secondary	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	No
Secondary	New MRI-detected subclinical cerebral ischaemia		1 year	No