Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation

Study Overview
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Brief Summary
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This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.

Official Title
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Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Conventional CLOSE-guided pulmonary vein isolation
* Procedure: High power short duration pulmonary vein isolation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years Patients scheduled for a first PVI only for paroxysmal atrial fibrillation (AF) (self-terminating or <7days) or persistent AF (persistent AF is defined as having an AF episode >7d); (patients with paroxysmal AF or short-standing persistent AF presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial) Patients willing to sign informed consent Exclusion Criteria: Patients with long-standing persistent AF (long-standing persistent AF is defined as having an AF episode >1yr) Previous ablation for AF Left atrium antero-posterior diameter >50 mm (parasternal long axis view, PLAX) AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause Left atrial appendage (LAA) thrombus. LAA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI. Left ventricular ejection fraction <35%. Cardiac surgery within the previous 90 days. Expecting cardiac transplantation or other cardiac surgery within 180 days. Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days. Documented history of a thromboembolic event within the previous 90 days. Diagnosed atrial myxoma. Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment Women who are pregnant or who plan to become pregnant during the study. Acute illness or active infection at time of index procedure Advanced renal insufficiency Unstable angina. History of blood clotting or bleeding abnormalities. Contraindication to anticoagulation. Life expectancy less than 1 year. Presence of a condition that precludes vascular access. Unwilling or unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional group<br> | Procedure: Conventional CLOSE-guided pulmonary vein isolation<br>* Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in a temperature and flow-controlled mode (QMODE, target temperature 45°C, low flow temperature 40°C, cut-off temperature 50°C) with a power of 35W(posterior)/50W(anterior) (irrigation flow at 4-15ml/min). RF will be delivered until an ablation index (AI) of ≥400 at the posterior wall/roof/south pole and ≥550 at the anterior wall.<br>|
| Active Comparator: 90W-group<br> | Procedure: High power short duration pulmonary vein isolation<br>* Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in temperature-controlled mode (QMode+, target temperature 55°C, cut-off temperature 65°C) with a power of 90W (irrigation flow at 2-8ml/min). RF will be delivered for 4 sec at both the posterior and anterior wall.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural time | Comparison of the procedural time (in minutes) between groups | Procedure (At time of ablation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation | Atrial tachyarrhythmia will be monitored by Holter | Months 4-6 after ablation | 
| Radiofrequency (RF) ablation time | Comparison of the RF ablation time (in seconds) between groups | Procedure (At time of ablation) | 
| Fluoroscopy dose | Comparison of the fluoroscopy dose (Gy cm²) between groups | Procedure (At time of ablation) | 
| First pass isolation rate | Reconnection of the veins after adenosine injection or waiting time | Procedure (At time of ablation) |