Registry Evaluating AF Ablation Techniques

Study Overview
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Brief Summary
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The purpose of this observational registry is to prospectively collect procedure efficiency, safety and acute and long term outcome data from catheter ablation procedures as treatment of paroxysmal atrial fibrillation, using the following treatment modalities: Cryoballoon ablation Manual guided RF ablation using Contact Force catheters Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings

Official Title
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Prospective, Multicenter, Non-randomized Observational Registry Conducted at High Volume Experienced Treatment Centers Utilizing the Most Current AF Ablation Techniques.

Conditions
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Atrial Fibrillation, Catheter Ablation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented Paroxysmal Atrial Fibrillation Eligibility for Pulmonary Vein Isolation by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure Signed the informed consent to participate in the registry Exclusion Criteria: Younger than 18 years of age Prior AF ablation procedure (including MAZE procedure) Prior ablation of Non-AF Arrhythmia within 3 months of enrollment Presence of cardiac thrombus Other AF ablations performed during procedure (e.g. lines, rotor, CFAE's etc) Active endocarditis or systemic infection Life expectancy < 1 year Pregnancy

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 |
| --- | --- |
| Manual guided RF ablation<br>Patients with paroxysmal atrial fibrillation treated with Manual guided RF ablation using Contact Force catheters | |
| Cryoballoon ablation<br>Patients with paroxysmal atrial fibrillation treated with Cryoballoon ablation. Cryoballoon: Arctic Front Advance, Medtronic - 28 mm | |
| RMN guided RF ablation - High power<br>Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings. High power ablation settings: a minimum of 40 Watt, 43grC, flow 17ml/min. Higher voltages (e.g. anterior wall) are allowed with respect to the operators' preference. | |
| RMN guided RF ablation - Low power<br>Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings. Low power ablation settings: a maximum of 39 Watt, 43grC, flow 17ml/min. Lower voltages are allowed with respect to the operators' preference. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Procedure time (minutes) | During ablation procedure | 
| Fluoroscopy time | Fluoroscopy time (minutes) | During ablation procedure | 
| Transseptal time | Transseptal time (time from insertion of catheters until transseptal puncture) (minutes) | During ablation procedure | 
| Left atrial dwell time | Left atrial dwell time (time from LA entry until removal of catheters) (minutes) | During ablation procedure | 
| PVI ablation time | PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes) | During ablation procedure | 
| Ablation time per pulmonary vein | Ablation time per pulmonary vein (minutes) | During ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Pass Isolation | First Pass Isolation (i.e. Successful isolation of PVs after the first ablation attempt) | During ablation procedure | 
| Acute success | Acute success (Successful electrical isolation of PVs at the end of procedure) | During ablation procedure | 
| TouchUp rates | TouchUp rates (additional applications for successful PV isolation) | During ablation procedure | 
| Long-term success | Long-term success (freedom of atrial fibrillation 12 months after ablation) | From the date of procedure until 1 year | 
| Procedure-related adverse-events | Procedure-related adverse-events | From the date of procedure until 7 days | 
| Long-term adverse events | Long-term adverse events | From the date of procedure until 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryoballoon, Paroxysmal Atrial Fibrillation, Catheter Ablation, Radiofrequency ablation, Remote Magnetic Navigation