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

This study has been terminated.
(Study terminated based on decision of Sponsor.)
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT00477230
First received: May 21, 2007
Last updated: June 26, 2012
Last verified: June 2012
  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:

  • 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 Intervention Phase
Atrial Fibrillation
Device: Endoscopic Ablation System
Drug: Standard Anti-arrhythmic Drug (AAD) Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)

Resource links provided by NLM:


Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • Freedom for Symptomatic Episode of Atrial Fibrillation at One Year [ Time Frame: One Year ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: March 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Additional Information:
No publications provided

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT00477230     History of Changes
Other Study ID Numbers: ENABLE 25-2064
Study First Received: May 21, 2007
Results First Received: June 26, 2012
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by CardioFocus:
AF
PAF
paroxysmal atrial fibrillation
ablation
failed drugs

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

ClinicalTrials.gov processed this record on November 20, 2014