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A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI only | Active Comparator | Patients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF. |
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| PVI + IM | Experimental | Patients in this arm will undergo standard wide area circumferential pulmonary veins isolation along with radiofrequency energy and additional RF ablation guided by individualised mapping with Cartofinder to treat their AF. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary veins isolation + Cartofinder-guided ablation | Procedure | The individualised mapping with Cartofinder intends to identify areas with the repetitive atrial activation patterns which are targeted with focal or linear ablation anchored on at least one end in an anatomical or electrical barrier. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial arrhythmia | Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs | 12 monts |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation | Freedom from atrial fibrillation without the use of antiarrhythmic drugs | 12 months |
| Atrial fibrillation burden reduction | Reduction of the atrial fibrillation burden by 75% compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vias Markides, MD, FESC | Contact | 020 7352 8121 | v.markides@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Vias Markides, MD, FESC | Royal Brompton Hospital, London, UK | Study Director |
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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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|
| Pulmonary veins isolation | Procedure | Wide area circumferential pulmonary veins isolation |
|
| 12 months |
| Absolute atrial fibrillation burden | Absolute atrial fibrillation burden after a single, first-time ablative procedure guided by individualised mapping vs. standard approach. | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |