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

This study has been withdrawn prior to enrollment.
(Study methodology redesigned)
Sponsor:
Information provided by (Responsible Party):
Neil Sulke, Eastbourne General Hospital
ClinicalTrials.gov Identifier:
NCT01503268
First received: December 30, 2011
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Device: Implantation of implantable loop recorder
Procedure: Percutaneous ablation of atrial fibrillation
Procedure: Surgical ablation of atrial fibrillation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders

Resource links provided by NLM:


Further study details as provided by Eastbourne General Hospital:

Primary Outcome Measures:
  • Reduction in AF burden after ablation [ Time Frame: One year ] [ Designated as safety issue: No ]
    Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder

  • Time to recurrence of persistent AF [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recurrence of atrial fibrillation after ablation [ Time Frame: One year ] [ Designated as safety issue: No ]
    Time to first detected episode of atrial fibrillation after ablation, outside a 3 month blanking period

  • Time to recurrence of symptomatic atrial fibrillation after ablation [ Time Frame: One year ] [ Designated as safety issue: No ]
    Time to first detected symptomatic episode of atrial fibrillation after ablation, outside a 3 month blanking period

  • New MRI-detected subclinical cerebral ischaemia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503268

Locations
United Kingdom
Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
Eastbourne District General Hospital
Eastbourne, East Sussex, United Kingdom, BN21 2UD
Sponsors and Collaborators
Eastbourne General Hospital
Investigators
Principal Investigator: A N Sulke, MD Eastbourne General Hospital
Principal Investigator: S S Furniss, MD Eastbourne General Hospital
  More Information

No publications provided

Responsible Party: Neil Sulke, Consultant Cardiologist, Eastbourne General Hospital
ClinicalTrials.gov Identifier: NCT01503268     History of Changes
Other Study ID Numbers: ACTUAL 1.0
Study First Received: December 30, 2011
Last Updated: June 19, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Eastbourne General Hospital:
Atrial fibrillation
Ablation
Percutaneous ablation
Minimally-invasive thoracoscopic ablation
Implantable loop recorder

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014