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

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.

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

Conditions
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Heart Diseases, Arrhythmia, 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: 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
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 |
| --- | --- | --- |
| The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up | The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period). | 12-months | 
| Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events. | Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block. | 7 days of the AF ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Acute Success | Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV). | End of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Paroxysmal Atrial Fibrillation