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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00519194
First received: August 20, 2007
Last updated: May 14, 2014
Last verified: May 2014

August 20, 2007
May 14, 2014
April 2009
March 2013   (final data collection date for primary outcome measure)
Freedom From Atrial Fibrillation in the Absence of Any AF Therapies [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.
Not Provided
Complete list of historical versions of study NCT00519194 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
CONcomitant eValuation of Epicor Left atRial Therapy for AF
CONcomitant eValuation of Epicor Left atRial Therapy for AF

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).

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • 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
Experimental: Epicor Cardiac Ablation
Interventions:
  • Device: Epicor LP Cardiac Ablation System
  • Procedure: Surgical ablation of permanent AF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
112
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00519194
051.13
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Mark Groh, MD Mission Hospitals
St. Jude Medical
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP