Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs

Stopped early · Phase 3

Conditions studied: Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT00477230

Run by

CardioFocus

People needed

64

Starts

2007-03-01

Expected to finish

2009-05-01

Last updated by the study team

2012-06-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 80 years old
• Paroxysmal atrial fibrillation (AF)
• Frequent episodes of AF
• Failed at least 1 drug treatment
• Others

You may not qualify if…

• Others

Where it is running

• Arizona Arrhythmia Consultants — Scottsdale, Arizona, United States
• Mercy General Hospital — Sacramento, California, United States
• University of California at San Francisco — San Francisco, California, United States
• St. John's Health Center — Santa Monica, California, United States
• Palm Beach Heart Research Institute — Atlantis, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Indiana University, Krannert Institute of Cardiology — Indianapolis, Indiana, United States
• Genesis Medical Center — Davenport, Iowa, United States
• University of Michigan — Ann Arbor, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• St. Luke's-Roosevelt — New York, New York, United States
• Strong Memorial Hosptial - University of Rochester — Rochester, New York, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Texas Cardiac Arrhythmia Research — Austin, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Sentara Cardiovascular Research Institute — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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