Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders: The ACTUAL Study (ACTUAL)
Primary Purpose
Atrial Fibrillation
Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Implantation of implantable loop recorder
Percutaneous ablation of atrial fibrillation
Surgical ablation of atrial fibrillation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Ablation, Percutaneous ablation, Minimally-invasive thoracoscopic ablation, Implantable loop recorder
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
Sites / Locations
- Royal Sussex County Hospital
- Eastbourne District General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Percutaneous ablation
Surgical ablation
DCCV
Arm Description
Direct current cardioversion
Outcomes
Primary Outcome Measures
Reduction in AF burden after ablation
Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder
Time to recurrence of persistent AF
Secondary Outcome Measures
Time to recurrence of atrial fibrillation after ablation
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 to first detected symptomatic episode of atrial fibrillation after ablation, outside a 3 month blanking period
New MRI-detected subclinical cerebral ischaemia
Full Information
NCT ID
NCT01503268
First Posted
December 30, 2011
Last Updated
June 19, 2013
Sponsor
Eastbourne General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01503268
Brief Title
Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders: The ACTUAL Study
Acronym
ACTUAL
Official Title
Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Study methodology redesigned
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastbourne General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Ablation, Percutaneous ablation, Minimally-invasive thoracoscopic ablation, Implantable loop recorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous ablation
Arm Type
Active Comparator
Arm Title
Surgical ablation
Arm Type
Active Comparator
Arm Title
DCCV
Arm Type
Active Comparator
Arm Description
Direct current cardioversion
Intervention Type
Device
Intervention Name(s)
Implantation of implantable loop recorder
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous ablation of atrial fibrillation
Intervention Description
Catheter-based percutaneous ablation of atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
Surgical ablation of atrial fibrillation
Intervention Description
Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation
Primary Outcome Measure Information:
Title
Reduction in AF burden after ablation
Description
Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder
Time Frame
One year
Title
Time to recurrence of persistent AF
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to recurrence of atrial fibrillation after ablation
Description
Time to first detected episode of atrial fibrillation after ablation, outside a 3 month blanking period
Time Frame
One year
Title
Time to recurrence of symptomatic atrial fibrillation after ablation
Description
Time to first detected symptomatic episode of atrial fibrillation after ablation, outside a 3 month blanking period
Time Frame
One year
Title
New MRI-detected subclinical cerebral ischaemia
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A N Sulke, MD
Organizational Affiliation
Eastbourne General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S S Furniss, MD
Organizational Affiliation
Eastbourne General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Sussex County Hospital
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Eastbourne District General Hospital
City
Eastbourne
State/Province
East Sussex
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders: The ACTUAL Study
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