Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs (ENABLE)
This study has been terminated.
(Study terminated based on decision of Sponsor.)
Sponsor:
CardioFocus
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT00477230
First received: May 21, 2007
Last updated: June 26, 2012
Last verified: June 2012
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Purpose
The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are:
- A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter
- Standard drug therapy (antiarrhythmic drugs)
To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you.
Eligibility Criteria
Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include:
- 18 to 80 years of age
- Frequent episodes of AF
- Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)
- Other criteria
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Device: Endoscopic Ablation System Drug: Standard Anti-arrhythmic Drug (AAD) Therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF) |
Resource links provided by NLM:
Further study details as provided by CardioFocus:
Primary Outcome Measures:
- Freedom for Symptomatic Episode of Atrial Fibrillation at One Year [ Time Frame: One Year ] [ Designated as safety issue: No ]
| Enrollment: | 64 |
| Study Start Date: | March 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Single ablation procedure with Endoscopic Ablation System
|
Device: Endoscopic Ablation System
Single ablation procedure with Endoscopic Ablation System
|
|
Active Comparator: 2
Medication
|
Drug: Standard Anti-arrhythmic Drug (AAD) Therapy
Medication as prescribed by physician.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 to 80 years old
- Paroxysmal atrial fibrillation (AF)
- Frequent episodes of AF
- Failed at least 1 drug treatment
- Others
Exclusion Criteria:
- Others
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477230
Locations
| United States, Arizona | |
| Arizona Arrhythmia Consultants | |
| Scottsdale, Arizona, United States, 85260 | |
| United States, California | |
| Mercy General Hospital | |
| Sacramento, California, United States, 95819-3633 | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94143 | |
| St. John's Health Center | |
| Santa Monica, California, United States | |
| United States, Florida | |
| Palm Beach Heart Research Institute | |
| Atlantis, Florida, United States, 33462 | |
| Florida Hospital | |
| Orlando, Florida, United States | |
| United States, Indiana | |
| Indiana University, Krannert Institute of Cardiology | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Genesis Medical Center | |
| Davenport, Iowa, United States | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States | |
| United States, New York | |
| St. Luke's-Roosevelt | |
| New York, New York, United States | |
| Strong Memorial Hosptial - University of Rochester | |
| Rochester, New York, United States, 14627 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| University of Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19096 | |
| United States, Texas | |
| Texas Cardiac Arrhythmia Research | |
| Austin, Texas, United States, 78705 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States | |
| Sentara Cardiovascular Research Institute | |
| Norfolk, Virginia, United States, 23507 | |
Sponsors and Collaborators
CardioFocus
Investigators
| Principal Investigator: | Vivek Reddy, MD | University of Miami |
| Principal Investigator: | Andrea Natale, MD | Texas Cardiac Arrhythmia |
| Study Director: | Burke Barrett | CardioFocus, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | CardioFocus |
| ClinicalTrials.gov Identifier: | NCT00477230 History of Changes |
| Other Study ID Numbers: | ENABLE 25-2064 |
| Study First Received: | May 21, 2007 |
| Results First Received: | June 26, 2012 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by CardioFocus:
|
AF PAF paroxysmal atrial fibrillation ablation failed drugs |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013