Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01057394
First received: January 26, 2010
Last updated: June 19, 2012
Last verified: June 2012

January 26, 2010
June 19, 2012
December 2009
June 2011   (final data collection date for primary outcome measure)
Rate and safety of permanent Pulmonary Vein Isolation of EAS-AC compared to EAM guided radiofrequency ablation [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01057394 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)
Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)

To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.

  1. visually guided ablation (VGA) using the EAS-AC and
  2. radiofrequency ablation
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
Device: Endoscopically Guided Ablation
Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
  • Active Comparator: Radiofrequency Ablation
    Intervention: Device: Endoscopically Guided Ablation
  • Experimental: Visually Guided Ablation
    Intervention: Device: Endoscopically Guided Ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptomatic, Paroxysmal Atrial Fibrillation (AF)
  • 18 to 75 Years of age
  • Others

Exclusion Criteria:

  • Generally good overall health as determined by multiple criteria
  • Willing to participate in a study
  • Others
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Italy
 
NCT01057394
25-2758
No
CardioFocus
CardioFocus
Not Provided
Principal Investigator: Vivek Reddy, MD The Mount Sinai Hospital, New York City
CardioFocus
June 2012

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