Clinical trial NCT01503268: Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders: The ACTUAL Study
Official title: Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Ablation
Percutaneous ablation
Minimally-invasive thoracoscopic ablation
Implantable loop recorder
Lead sponsor: Eastbourne General Hospital
Sponsor class: OTHER
First posted: 2012-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction in AF burden after ablation
timeFrame: One year
measure: Time to recurrence of persistent AF
timeFrame: 1 year
Secondary outcomes:
measure: Time to recurrence of atrial fibrillation after ablation
timeFrame: One year
measure: Time to recurrence of symptomatic atrial fibrillation after ablation
timeFrame: One year
measure: New MRI-detected subclinical cerebral ischaemia
timeFrame: 1 year
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
state: East Sussex
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
state: East Sussex
Study officials:
affiliation: Eastbourne General Hospital
name: A N Sulke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastbourne General Hospital
name: S S Furniss, MD
role: PRINCIPAL_INVESTIGATOR
References: