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

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. Identifier: NCT00477230
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
Information provided by (Responsible Party):

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

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
Drug: Standard Anti-arrhythmic Drug (AAD) Therapy
Medication as prescribed by physician.

Primary Outcome Measures :
  1. 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

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 identifier (NCT number): NCT00477230

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
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 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:
paroxysmal atrial fibrillation
failed drugs

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents