CONcomitant eValuation of Epicor Left atRial Therapy for AF

Stopped early · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT00519194

Run by

Abbott Medical Devices

People needed

112

Starts

2009-04-01

Expected to finish

2013-03-01

Last updated by the study team

2019-02-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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