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In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) compared to the control group which will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds).
BACKGROUND: In a population of paroxysmal AF 'CLOSE'-guided PVI (Target Ablation index (AI) >550 and >400 for anterior and posterior wall respectively, interlesion distance ≤6mm) has been shown to obtain single-procedure durable PV isolation. However, the optimal RF power and stability criteria is unknown.
OBJECTIVES: With this study, we aim at evaluation the efficacy and the safety of higher power (45 watts) and stricter stability criteria (3 mm for 3 sec) as compared to a standard CLOSE protocol (35 watts with stability of 3 mm for 8 sec) in patients referred for a first ablation for paroxysmal AF.
POPULATION: Eligible patients are patients with paroxysmal AF who are planned for a 'CLOSE'-guided PV isolation for paroxysmal AF. At the time of the procedrual planning, we will ask the patient his/her consent for collectio of data. We aim at including 100 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High power group | Active Comparator | The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds). |
|
| Standard group | Active Comparator | The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High power CLOSE-guided PVI ablation | Procedure | CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Acute procedural success | First pass pulmonary vein isolation confirmed after adenosine injection | At time of ablation |
| Safety: Absence of clinical complications | Absence of clinical complications during the procedure and up to one month thereafter | From time of ablation to 1 month post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural duration time | At time of ablation | |
| Duration for pulmonary vein isolation | At time of ablation | |
| Fluoroscopic duration and irradiation (AK) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology | Bruges | 8000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33300809 | Result | Wielandts JY, Kyriakopoulou M, Almorad A, Hilfiker G, Strisciuglio T, Phlips T, El Haddad M, Lycke M, Unger P, Le Polain de Waroux JB, Vandekerckhove Y, Tavernier R, Duytschaever M, Knecht S. Prospective Randomized Evaluation of High Power During CLOSE-Guided Pulmonary Vein Isolation: The POWER-AF Study. Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009112. doi: 10.1161/CIRCEP.120.009112. Epub 2020 Dec 10. |
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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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| Standard CLOSE-guided PVI ablation | Procedure | Standard AF ablation according to the CLOSE-protocol |
|
| At time of ablation |
| Amount of ablation points associated with temperature rise | At time of ablation |
| Maximum temperature in case of temperature rise | At time of ablation |
| Incidence of adverse events related to ablation | From time of ablation to 6 months post procedure |
| First pass encirclement isolation rate | At time of ablation |
| Reconnection rate after adenosine | At time of ablation |
| Number of dislocations | At time of ablation |
| Number of ablation points with an oesophageal temperature rise >39°C | At time of ablation |
| Maximum temperature in case of oesophageal temperature rise | At time of ablation |
| Longterm procedural success rate | Six months after ablation |
| D013568 |
| Pathological Conditions, Signs and Symptoms |