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Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation (En-GARDE)

This study has been terminated.
(Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.)
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01057394
First received: January 26, 2010
Last updated: July 27, 2016
Last verified: July 2016

January 26, 2010
July 27, 2016
December 2009
June 2011   (final data collection date for primary outcome measure)
Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).
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 ]
Complete list of historical versions of study NCT01057394 on ClinicalTrials.gov Archive Site
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Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
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
The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation.
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 PVI Ablation
    Endoscopically Guided Ablation using the EAS-AC
  • Device: RF PVI Ablation
    Radiofrequency ablation
  • Active Comparator: Radiofrequency Ablation
    PVI using RF ablation
    Intervention: Device: RF PVI Ablation
  • Experimental: Visually Guided Ablation
    PVI using visually guided ablation with an endoscopic ablation system
    Intervention: Device: Endoscopically guided PVI Ablation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
June 2011
June 2011   (final data collection date for primary outcome measure)
  • Symptomatic, Paroxysmal Atrial Fibrillation (AF)
  • 18 to 75 Years of age
  • Generally good overall health as determined by multiple criteria
  • Willing to participate in a study
  • Others
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Italy
 
NCT01057394
25-2758
No
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CardioFocus
CardioFocus
Not Provided
Principal Investigator: Vivek Reddy, MD The Mount Sinai Hospital, New York City
CardioFocus
July 2016

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