Clinical trial NCT00519194: CONcomitant eValuation of Epicor Left atRial Therapy for AF
Official title: CONcomitant eValuation of Epicor Left atRial Therapy for AF
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Arrhythmia
Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-08-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Freedom From Atrial Fibrillation in the Absence of Any AF Therapies
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: St. Agnes Medical Center
state: California
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Bradenton
country: United States
facility: Blake Medical Center
state: Florida
city: Pensacola
country: United States
facility: Cardiology Consultants, MD's PA (Baptist Hospital)
state: Florida
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Baltimore
country: United States
facility: Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation/Abbott NW Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Asheville
country: United States
facility: Mission Hospital, Inc
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Mission Hospitals
name: Mark Groh, MD
role: PRINCIPAL_INVESTIGATOR
References: