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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Freedom for Symptomatic Episode of Atrial Fibrillation at One Year [ Time Frame: One Year ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	CardioFocus
ClinicalTrials.gov Identifier:	NCT00477230 History of Changes
Other Study ID Numbers:	ENABLE 25-2064
First Posted:	May 23, 2007
Results First Posted:	June 27, 2012
Last Update Posted:	June 27, 2012
Last Verified:	June 2012

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