High Power Short Duration Ablation for Paroxysmal AF With High Density Multi Directional Mapping (LOWE AF HD Study).

Study Overview
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Brief Summary
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The LOWE AF HD is a prospective, single-center, non-randomized study to assess safety, efficacy, acute and long-term outcome data of a specific ablation approach as treatment of paroxysmal atrial fibrillation.

Detailed Description
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Pulmonary vein isolation using radiofrequency (RF) ablation is acknowledged used treatment strategy for atrial fibrillation, many different approaches are recently implemented. The specific approach used in this study includes: Multi-directional high-density mapping High power - short duration settings Contact force sensing ablation catheter The aim of LOWE AF HD is to assess the acute safety and success rate of this approach and also the long-term outcome assessed by atrial recurrences arrythmias collected by an implantable loop recorder.

Official Title
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Loop Recorder Evaluation in Patients Treated With High Power Short Duration Ablation for Paroxysmal Atrial Fibrillation With High Density Multi Directional Mapping (LOWE AF HD Study)

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal AF 18 Years and older. Able and willing to provide written informed consent prior to any clinical investigation related procedure Able and willing to complete all required study procedures through 12 months Life expectancy less than 12 months Exclusion Criteria: Persistent or long-standing persistent AF Presence of thrombus in left atrium and left atrium appendage MI, CABG or PCI within preceding 3 months Left atrial diameter > 5.0 cm LVEF < 35% NYHA class III or IV Previous atrial fibrillation ablation procedure with high density and high-power short duration approach Previous tricuspid or mitral valve repair surgery

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High Power Atrial Fibrillation Ablation<br>In our center, routine medical care for atrial fibrillation ablation includes: Multidirectional high-density mapping High power - short duration settings Contact force sensing ablation catheter | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Procedural Success Rate | Acute procedural success defined as electrical isolation of all pulmonary veins, confirmed by the high-density voltage remap and loss of pace capture along ablation line after complete isolation. | 1 day | 
| Rate of patients without Atrial Fibrillation recurrences | Freedom from Atrial Fibrillation (AF) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL), lasting longer than 30 second, assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR). | 12 months after 3-months blanking period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events rate | Procedural and post procedural safety assessed by reporting all adverse events in the first 30 days after ablation | 1 month | 
| Ablation Procedure Time | Complete procedure time (minutes) | 1 day | 
| Ablation Fluoroscopic Time | Fluoroscopic time recorded (minutes) during ablation procedure | 1 day | 
| Number of radiofrequency applications | Number of radiofrequency applications reported for each patient during ablation procedure. | 1 day | 
| Total radiofrequency ablation time | Total time (minutes) of radiofrequency applications in each patient during ablation procedure. | 1 day | 
| First pass pulmonary vein isolation | Number of patients in which PV isolation is obtained at first attempt. | 1 day | 
| Number of atrial fibrillation events | Number of AF events symptomatic and asymptomatic assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR). | 12 months | 
| Atrial Fibrillation Burden | AF Burden (in minutes) recorded at 12 months (after 3-months blanking period) of follow-up by Implantable Loop Recorder. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AF, High Power - Short Duration Ablation, High Density Mapping