Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs (ENABLE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00477230 |
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Recruitment Status :
Terminated
(Study terminated based on decision of Sponsor.)
First Posted : May 23, 2007
Results First Posted : June 27, 2012
Last Update Posted : June 27, 2012
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Sponsor:
CardioFocus
Information provided by (Responsible Party):
CardioFocus
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation | Device: Endoscopic Ablation System Drug: Standard Anti-arrhythmic Drug (AAD) Therapy | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF) |
| Study Start Date : | March 2007 |
| Actual Primary Completion Date : | May 2009 |
| Actual Study Completion Date : | May 2009 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Familial atrial fibrillation
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Single ablation procedure with Endoscopic Ablation System
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Device: Endoscopic Ablation System
Single ablation procedure with Endoscopic Ablation System |
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Active Comparator: 2
Medication
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Drug: Standard Anti-arrhythmic Drug (AAD) Therapy
Medication as prescribed by physician. |
Primary Outcome Measures :
- Freedom for Symptomatic Episode of Atrial Fibrillation at One Year [ Time Frame: One Year ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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. |
| Responsible Party: | CardioFocus |
| ClinicalTrials.gov Identifier: | NCT00477230 History of Changes |
| Other Study ID Numbers: |
ENABLE 25-2064 |
| First Posted: | May 23, 2007 Key Record Dates |
| Results First Posted: | June 27, 2012 |
| Last Update Posted: | June 27, 2012 |
| Last Verified: | June 2012 |
Keywords provided by CardioFocus:
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AF PAF paroxysmal atrial fibrillation ablation failed drugs |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Anti-Arrhythmia Agents |