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
  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 PVI Ablation
Device: RF PVI 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 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).


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
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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:
Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT01057394     History of Changes
Other Study ID Numbers: 25-2758 
Study First Received: January 26, 2010
Results First Received: April 18, 2016
Last Updated: July 27, 2016
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 August 24, 2016