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

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ClinicalTrials.gov Identifier: NCT01057394
Recruitment Status : Terminated (Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.)
First Posted : January 27, 2010
Results First Posted : August 1, 2016
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
CardioFocus

Study Description
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Brief Summary:

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

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: Endoscopically guided PVI Ablation Device: RF PVI Ablation Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)
Study Start Date : December 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Radiofrequency Ablation
PVI using RF ablation
 Device: RF PVI Ablation
Radiofrequency ablation
Experimental: Visually Guided Ablation
PVI using visually guided ablation with an endoscopic ablation system
 Device: Endoscopically guided PVI Ablation
Endoscopically Guided Ablation using the EAS-AC


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation [ Time Frame: 3 Months ]
    Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057394


Locations
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Czech Republic
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czech Republic, 140 21
Italy
Catholic University of the Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
CardioFocus
Investigators
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Principal Investigator: Vivek Reddy, MD The Mount Sinai Hospital, New York City
More Information
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Additional Information:

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Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT01057394    
Other Study ID Numbers: 25-2758
First Posted: January 27, 2010    Key Record Dates
Results First Posted: August 1, 2016
Last Update Posted: August 1, 2016
Last Verified: July 2016
Keywords provided by CardioFocus:
Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes