Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent 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 using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially to treat longstanding persistent Atrial Fibrillation (AF) patients.

Official Title
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Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of LongStanding Persistent Atrial Fibrillation

Conditions
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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) History of AF for less than or equal to 10 years Provided written informed consent Symptomatic longstanding persistent Atrial Fibrillation (AF). 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 History of pericarditis Previous cerebrovascular accident (CVA), excluding fully resolved TIA Patients who have 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 nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter 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 assessment 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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Longstanding Persistent Atrial Fibrillation, AF, Chronic AF, RF Ablation, nContact Surgical, Therapy Cool Path Ablation Catheter, St. Jude Medical