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
  Purpose

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 Intervention Phase
Paroxysmal Atrial Fibrillation
Device: Endoscopically Guided Ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiofrequency Ablation Device: Endoscopically Guided Ablation
Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
Experimental: Visually Guided Ablation Device: Endoscopically Guided Ablation
Visually Guided Ablation using the EAS-AC Radiofrequency Ablation

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057394

Locations
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
Principal Investigator: Vivek Reddy, MD The Mount Sinai Hospital, New York City
  More Information

Additional Information:
No publications provided

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT01057394     History of Changes
Other Study ID Numbers: 25-2758
Study First Received: January 26, 2010
Last Updated: June 19, 2012
Health Authority: Europe: Post-market study

Keywords provided by CardioFocus:
Atrial Fibrillation

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

ClinicalTrials.gov processed this record on September 16, 2014