CONcomitant eValuation of Epicor Left atRial Therapy for AF (CONVERT-AF)

Abbott

Status: Terminated

Conditions: Atrial Fibrillation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519194

051.13

Details and patient eligibility

About

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).

Enrollment: 112 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Epicor Cardiac Ablation

Experimental group

Treatment:

Procedure: Surgical ablation of permanent AF

Device: Epicor LP Cardiac Ablation System