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Study methodology redesigned
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous ablation | Active Comparator |
| |
| Surgical ablation | Active Comparator |
| |
| DCCV | Active Comparator | Direct current cardioversion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of implantable loop recorder | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in AF burden after ablation | Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder | One year |
| Time to recurrence of persistent AF | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to recurrence of symptomatic atrial fibrillation after ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A N Sulke, MD | Eastbourne General Hospital | Principal Investigator |
| S S Furniss, MD | Eastbourne General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Sussex County Hospital | Brighton | East Sussex | BN2 5BE | United Kingdom | ||
| Eastbourne District General Hospital |
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|
| Percutaneous ablation of atrial fibrillation | Procedure | Catheter-based percutaneous ablation of atrial fibrillation |
|
| Surgical ablation of atrial fibrillation | Procedure | Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation |
|
Time to first detected symptomatic episode of atrial fibrillation after ablation, outside a 3 month blanking period
| One year |
| New MRI-detected subclinical cerebral ischaemia | 1 year |
| Eastbourne |
| East Sussex |
| BN21 2UD |
| United Kingdom |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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