Back to resultsPost-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation (En-GARDE)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Endoscopically guided PVI Ablation
RF PVI Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Atrial Fibrillation
Eligibility 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
Sites / Locations
- Institute for Clinical and Experimental Medicine (IKEM)
- Catholic University of the Sacred Heart
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Radiofrequency Ablation
Visually Guided Ablation
Arm Description
PVI using RF ablation
PVI using visually guided ablation with an endoscopic ablation system
Outcomes
Primary Outcome Measures
Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation
Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01057394
Brief Title
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
Acronym
En-GARDE
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioFocus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.
visually guided ablation (VGA) using the EAS-AC and
radiofrequency ablation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency Ablation
Arm Type
Active Comparator
Arm Description
PVI using RF ablation
Arm Title
Visually Guided Ablation
Arm Type
Experimental
Arm Description
PVI using visually guided ablation with an endoscopic ablation system
Intervention Type
Device
Intervention Name(s)
Endoscopically guided PVI Ablation
Intervention Description
Endoscopically Guided Ablation using the EAS-AC
Intervention Type
Device
Intervention Name(s)
RF PVI Ablation
Intervention Description
Radiofrequency ablation
Primary Outcome Measure Information:
Title
Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation
Description
Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
The Mount Sinai Hospital, New York City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine (IKEM)
City
Prague
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
Catholic University of the Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Links:
URL
http://www.cardiofocus.com
Description
Related Info
Learn more about this trial
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
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