THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS

Study Overview
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Brief Summary
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This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.

Detailed Description
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The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.

Official Title
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THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access

Conditions
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Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: THERMOCOOL® SMARTTOUCH™ Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have had at least 3 atrial fibrillation episodes within 6 months of this study Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes 18 years of age or older Exclusion Criteria including, but not limited to: Have had previous ablation for atrial fibrillation Have take amiodarone within 6 months of this study Have had any heart surgery within the last 60 days Have had a heart attack within the last 60 days Females who are pregnant or breast feeding

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
Intervention Model: Single Group Assignment
Interventional Model Description: This study had a single arm: catheter ablation for PAF
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THERMOCOOL® SMARTTOUCH™ Catheter<br> | Device: THERMOCOOL® SMARTTOUCH™ Catheter<br>* AF Ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias | Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as atrial tachyarrhythmias) based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures | Day 91-361 | 
| Incidence of Primary Adverse Events Within Specified Study Period | Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block. | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-procedural Serious Adverse Events | Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure | Within 8-30 days post procedure | 
| Percentage of Subjects Achieved Acute Effectiveness | Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins | 5 hours of procedure time | 
| Late Onset Serious Adverse Events | Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure | From 31 days post procedure to month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug refractory, Atrial fibrillation, Antiarrhythmic drug failure, Atrial tachyarrhythmias