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Internal protocol review
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Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can be technically difficult. This study compares percutaneous ablation to thoracoscopic surgical AF ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pecutaneous AF ablation | Active Comparator | Percutaneous catheter ablation of atrial fibrillation |
|
| Surgical AF ablation | Active Comparator | Minimally invasive thoracoscopic surgical ablation of atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical AF ablation | Procedure | Minimally invasive thoracoscopic surgical ablation of atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of persistent AF by 12 months after ablation | Mean time to recurrence of persistent AF after ablation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AF burden after AF ablation | Detected by ILR | 12 months |
| Time to first episode of symptomatic AF after ablation | Time to first episode of symptomatic AF after ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life changes after AF ablation | 12 months | |
| Change in exercise capacity assessed by cardiopulmonary exercise testing (CPET) after AF ablation | 12 months | |
| Change in echocardiographic left atrial dimensions and function after AF ablation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Sulke, DM | Eastbourne General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastbourne General Hospital | Eastbourne | E Sussex | BN21 2UD | United Kingdom | ||
| Royal Sussex County Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Percutaneous AF ablation | Procedure | Percutaneous catheter ablation of atrial fibrillation |
|
| 12 months |
| Time to first episode of any AF after ablation | As detected by ILR | 12 months |
| Total number of AF episodes after AF ablation | As detected by ILR, outside blanking period | 12 months |
| Total number of AF episodes lasting greater than 6 minutes after AF ablation | As detected by ILR, outside blanking period | 12 months |
| New MRI-detected subclinical cerebral embolic events | 3 months |
| 12 months |
| Change in cognitive function as assessed by the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) instruments | 12 months |
| Brighton |
| East Sussex |
| BN2 5BE |
| United Kingdom |
| D013568 |
| Pathological Conditions, Signs and Symptoms |