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:
CardioFocus
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01057394
First received: January 26, 2010
Last updated: June 19, 2012
Last verified: June 2012
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Purpose
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.
- visually guided ablation (VGA) using the EAS-AC and
- 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:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
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
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 May 21, 2013