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| Name | Class |
|---|---|
| University Hospital Southampton NHS Foundation Trust | OTHER |
| The Royal Bournemouth Hospital | OTHER |
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Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF occurs in up to 10% of the population over the age of 60. It is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes.
Ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been shown to cure 90% of patients with intermittent (paroxysmal) AF.
The investigators currently use either one of two different catheters to create these burns inside the heart. The investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation.
The investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. The investigators objective is to study the differences between these two catheters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | WACA and PVI |
|
| 2 | Active Comparator | PVAC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WACA and PVI | Device | Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording | 1 year | |
| Procedural time for pulmonary vein isolation | Index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| All procedural complications | Index | |
| Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure | 6 months | |
| Quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pier D Lambiase, PhD | University College Hospital London NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Hospital London NHS Foundation Trust | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24843051 | Derived | McCready J, Chow AW, Lowe MD, Segal OR, Ahsan S, de Bono J, Dhaliwal M, Mfuko C, Ng A, Rowland ER, Bradley RJ, Paisey J, Roberts P, Morgan JM, Sandilands A, Yue A, Lambiase PD. Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial. Europace. 2014 Aug;16(8):1145-53. doi: 10.1093/europace/euu064. Epub 2014 May 19. |
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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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| PVAC | Device | Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence. |
|
|
| 6 months and 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |