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| Sponsored by: |
CardioFocus |
|---|---|
| Information provided by: | CardioFocus |
| ClinicalTrials.gov Identifier: | NCT00477230 |
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:
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:
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Procedure: Single ablation procedure with Endoscopic Ablation System |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF) |
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Single ablation procedure with Endoscopic Ablation System
|
Procedure: Single ablation procedure with Endoscopic Ablation System
Single ablation procedure with Endoscopic Ablation System
|
|
2: Active Comparator
Medication
|
Procedure: Single ablation procedure with Endoscopic Ablation System
Single ablation procedure with Endoscopic Ablation System
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Arizona Arrhythmia Consultants | |
| Scottsdale, Arizona, United States, 85260 | |
| United States, California | |
| St. John's Health Center | |
| Santa Monica, California, United States | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94143 | |
| Mercy General Hospital | |
| Sacramento, California, United States, 95819-3633 | |
| United States, Florida | |
| Florida Hospital | |
| Orlando, Florida, United States | |
| Palm Beach Heart Research Institute | |
| Atlantis, Florida, United States, 33462 | |
| 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 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| 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 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| Texas Cardiac Arrhythmia Research | |
| Austin, Texas, United States, 78705 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States | |
| Sentara Cardiovascular Research Institute | |
| Norfolk, Virginia, United States, 23507 | |
| Principal Investigator: | Vivek Reddy, MD | University of Miami |
| Principal Investigator: | Andrea Natale, MD | Texas Cardiac Arrhythmia |
| Study Director: | Burke Barrett | CardioFocus, Inc. |
More Information
| Responsible Party: | CardioFocus, Inc. ( Burke T. Barrett, Vice President, Regulatory & Clinical Affairs ) |
| Study ID Numbers: | ENABLE 25-2064 |
| Study First Received: | May 21, 2007 |
| Last Updated: | June 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00477230 |
| Health Authority: | United States: Food and Drug Administration |
|
AF PAF paroxysmal atrial fibrillation ablation failed drugs |
|
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
|
Pathologic Processes Cardiovascular Diseases |
