CONcomitant eValuation of Epicor Left atRial Therapy for AF

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac Ablation System for treating permanent atrial fibrillation during concomitant open chest and/or open heart surgery for one of more of the following procedures: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, coronary artery bypass surgery or patent foramen ovale (PFO closure).

Official Title
-----------------
CONcomitant eValuation of Epicor Left atRial Therapy for AF

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Epicor LP Cardiac Ablation System
* Procedure: Surgical ablation of permanent AF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years old Permanent AF defined as continuous AF lasting > one year OR non self-terminating AF lasting > seven days but no more than one year with at least one failed DC cardioversion Have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (PFO) closure or coronary artery bypass surgery Be able to take anticoagulation therapy Be able to fulfill study requirements Be able to sign study-specific informed consent Exclusion Criteria: Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy Prior cardiac surgery Presence of active endocarditis, local or system infection Presence of advanced heart failure (NYHA class > II, & LVEF < 20%) Intraaortic balloon pump, IV inotropes or vasoactive agents within 30 days Emergent cardiac surgery due to acute MI or acute mitral regurgitation Life expectancy < 1 year Major or progressive non-cardiac disease Presence of left atrial thrombi Left atrial diameter > 6.0 cm Any condition that prevents investigator from safely performing procedure Positive urine or serum pregnancy test Prior left atrial ablation Currently participating in another clinical research study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epicor Cardiac Ablation<br> | Device: Epicor LP Cardiac Ablation System<br>* Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery<br>Procedure: Surgical ablation of permanent AF<br>* Concomitant AF ablation during mitral valve surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Atrial Fibrillation in the Absence of Any AF Therapies | Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmia, Atrial Fibrillation