CONcomitant eValuation of Epicor Left atRial Therapy for AF

Atrial Fibrillation Clinical Trial

— CONVERT-AF  

Official title:

CONcomitant eValuation of Epicor Left atRial Therapy for AF

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00519194
• Other study ID #: 051.13
• Status: Terminated
• Phase: N/A
• Start date: April 2009
• Est. completion date: March 2013

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Epicor LP Cardiac Ablation System
Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery

Procedure:
• Surgical ablation of permanent AF
Concomitant AF ablation during mitral valve surgery

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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