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Clinical Trials/NCT01503268
NCT01503268
Withdrawn
Phase 4

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

Eastbourne General Hospital2 sites in 1 countryNovember 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Eastbourne General Hospital
Locations
2
Primary Endpoint
Time to recurrence of persistent AF
Status
Withdrawn
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
November 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Eastbourne General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Neil Sulke

Consultant Cardiologist

Eastbourne General Hospital

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

Outcomes

Primary Outcomes

Time to recurrence of persistent AF

Time Frame: 1 year

Reduction in AF burden after ablation

Time Frame: One year

Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder

Secondary Outcomes

  • New MRI-detected subclinical cerebral ischaemia(1 year)
  • Time to recurrence of atrial fibrillation after ablation(One year)
  • Time to recurrence of symptomatic atrial fibrillation after ablation(One year)

Study Sites (2)

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