Tailored Treatment of Permanent Atrial Fibrillation - Full Text View

Sponsor:	Ablation Frontiers
Information provided by:	Ablation Frontiers
ClinicalTrials.gov Identifier:	NCT00514735

Purpose

The purpose of the trial is to evaluate the safety and efficacy of the Ablation Frontiers Cardiac Ablation System compared to currently approved treatment options for atrial fibrillation.

Condition	Intervention	Phase
Atrial Fibrillation	Procedure: Ablation Frontiers Cardiac Ablation System (Arm 1- Experimental); DC Cardioversions (Arm 2- Active Comparator)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Tailored Treatment of Permanent Atrial Fibrillation - TTOP AF

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Ablation Frontiers:

Primary Outcome Measures:

Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ablation Management	Procedure: Ablation Frontiers Cardiac Ablation System (Arm 1- Experimental); DC Cardioversions (Arm 2- Active Comparator) Ablation procedures and/or DC Cardioversions
2: Active Comparator Medical Management	Procedure: Ablation Frontiers Cardiac Ablation System (Arm 1- Experimental); DC Cardioversions (Arm 2- Active Comparator) Ablation procedures and/or DC Cardioversions

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of symptomatic atrial fibrillation
Age between 18 and 70
Failure of at least one class I or III rhythm control AAD
Willingness, ability and commitment to participate in baseline and follow- up evaluations for the full length of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514735

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Locations

United States, Arizona
Arizona Arrhythmia Research Center
Scottsdale, Arizona, United States, 85251
United States, California
UCLA Cardiac Arrhythmia Center
Los Angeles, California, United States, 90095
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50309
Genesis Medical Center
Davenport, Iowa, United States, 52803
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cardiac Arrhythmia
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Spectrum Health Research Department
Grand Rapids, Michigan, United States, 49503
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Consultants in Cardiovascular Diseases
Erie, Pennsylvania, United States, 16502
United States, Texas
Texas Heart Institute at St. Luke's Episcopal
Houston, Texas, United States, 77030
Austin Heart
Austin, Texas, United States, 78756
United States, Virginia
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands

Sponsors and Collaborators

Ablation Frontiers

More Information

Additional Information:

Company website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ablation Frontiers, Inc. ( Jerald Cox, Director of Clinical Affairs )
Study ID Numbers:	AFI-30
Study First Received:	August 8, 2007
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00514735 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ablation Frontiers:

atrial fibrillation

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 27, 2009