Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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This is a multi-center, prospective, open label, feasibility clinical study,evaluating the safety and efficacy of the combined ablation procedure for the treatment of symptomatic paroxysmal atrial fibrillation.

Detailed Description
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The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure for the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (AF) patients, using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster NaviStar® ThermoCool® Diagnostic/Ablation deflectable Tip Catheter in conjunction with the Carto Navigation System endocardially.

Official Title
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Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Numeris®-AF Guided Coagulation System with VisiTrax®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years; < 80 years Left atrium less than or equal to 6.5 cm (TTE) Symptomatic paroxysmal AF Provided written informed consent Refractory to at least one AAD (class I, II, III or IV) Exclusion Criteria: Patients requiring concomitant surgery Left ventricular ejection fraction < 30% Pregnant or planning to become pregnant during study Co-morbid medical conditions that limit one year life expectancy Measured left ventricular wall thickness > 1.5 cm History of coagulopathy Previous cardiac surgery Right ventricular outflow tract obstruction History of pericarditis Previous cerebrovascular accident (CVA), excluding fully resolved TIA Patients who have severe chronic obstructive pulmonary disease (COPD) Patients who have an active infection or sepsis Patients who have uncorrected reversible cause(s) of AF Patients who are contraindicated for anticoagulants Patients who are being treated for arrhythmias other than AF Patients who have had any previous AF or left atrial catheter ablation Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Other: Numeris-AF Guided Coagulation System<br> | Device: Numeris®-AF Guided Coagulation System with VisiTrax®<br>* Combined epicardial / endocardial procedure using the Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster ThermoCool Catheter in conjunction with the Carto Navigation System endocardially.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF free off all Class I and III Anti Arrhythmic Drugs (AADs). | The primary efficacy data will be an evaluation of the number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) from 3 months through 12 months post procedure. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF free regardless of the Class I and III AADs status | The secondary efficacy data will be an evaluation of the number of subjects free from AF regardless of their Class I and III AADs status from 3 months through 12 months post procedure. | 12 months | 

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