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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00519194
First received: August 20, 2007
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition Intervention
Atrial Fibrillation
 Device: Epicor LP Cardiac Ablation System
Procedure: Surgical ablation of permanent AF

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CONcomitant eValuation of Epicor Left atRial Therapy for AF

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from atrial fibrillation in the absence of any AF therapies [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: April 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epicor Cardiac Ablation 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519194

Locations
United States, California
St. Agnes Medical Center
Fresno, California, United States, 93720
United States, Florida
Manatee Memorial Hospital
Bradenton, Florida, United States, 34208
Blake Medical Center
Bradenton, Florida, United States, 34209
United States, Illinois
NorthShore University Health System
Evanston, Illinois, United States, 60201
United States, Indiana
Community Hospital
Munster, Indiana, United States, 46321
United States, Maryland
Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital
Baltimore, Maryland, United States, 21218
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Minneapolis Heart Institute Foundation/Abbott NW Hospital
Minneapolis, Minnesota, United States, 55407
HealthEast St. Joseph's Hospital
St. Paul, Minnesota, United States, 55102
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
St. Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
Mission Hospital, Inc
Asheville, North Carolina, United States, 28801
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Mark Groh, MD Mission Hospitals
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00519194     History of Changes
Other Study ID Numbers: 051.13
Study First Received: August 20, 2007
Last Updated: January 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
Arrhythmia
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013