CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study. The POWERAF Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: High power CLOSE-guided PVI ablation
* Procedure: Standard CLOSE-guided PVI ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients referred for symptomatic paroxysmal AF and without advanced structural heart disease Signed Patient Informed Consent Form Age 18 years or older Able and willing to comply with all follow-up testing and requirements Exclusion Criteria: Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF) Previous ablation for AF LA antero-posterior diameter>50 mm (parasternal long axis view , PLAX) LVEF <35% (ejection fraction) AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause CABG procedure within the last three months Awaiting cardiac transplantation or other cardiac surgery Documented left atrial thrombus on imaging Diagnosed atrial myxoma Women who are pregnant or breastfeeding Acute illness or active systemic infection or sepsis Unstable angina Uncontrolled heart failure Myocardial infarction within the previous two months History of blood clotting or bleeding abnormalities Contraindication to anticoagulation therapy (ie, heparin or warfarin) Life expectancy less than 12 months Enrollment in any other study evaluating another device or drug Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction

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: High power group<br>The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds). | Procedure: High power CLOSE-guided PVI ablation<br>* CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)<br>|
| Active Comparator: Standard group<br>The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds) | Procedure: Standard CLOSE-guided PVI ablation<br>* Standard AF ablation according to the CLOSE-protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |