CONcomitant eValuation of Epicor Left atRial Therapy for AF

Not Applicable

Terminated

Interventions: Device: Epicor LP Cardiac Ablation System
Procedure: Surgical ablation of permanent AF

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Epicor Cardiac Ablation	Surgical ablation of permanent AF	-
Epicor Cardiac Ablation	Epicor LP Cardiac Ablation System	-

Primary Outcome Measures

Name	Time	Method
Freedom From Atrial Fibrillation in the Absence of Any AF Therapies	6 months	Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.

Secondary Outcome Measures

Name	Time	Method

Locations (15): University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
HealthEast St. Joseph's Hospital
🇺🇸
Saint Paul, Minnesota, United States
Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
Mission Hospital, Inc
🇺🇸
Asheville, North Carolina, United States
St. Francis Hospital
🇺🇸
Roslyn, New York, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
St. Agnes Medical Center
🇺🇸
Fresno, California, United States
Manatee Memorial Hospital
🇺🇸
Bradenton, Florida, United States
Blake Medical Center
🇺🇸
Bradenton, Florida, United States
NorthShore University Health System
🇺🇸
Evanston, Illinois, United States
Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
Minneapolis Heart Institute Foundation/Abbott NW Hospital
🇺🇸
Minneapolis, Minnesota, United States
Cardiology Consultants, MD's PA (Baptist Hospital)
🇺🇸
Pensacola, Florida, United States
Community Hospital
🇺🇸
Munster, Indiana, United States