HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
NCT ID: NCT01456000
Last Updated: 2016-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
405 participants
INTERVENTIONAL
2012-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EAS-AC (HeartLight)
Treatment with the EAS-AC.
EAS-AC (HeartLight)
Pulmonary vien isolation
Control Arm Ablation
Treatment with standard ablation.
Control Arm Ablation
Treatment with standard ablation.
Interventions
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EAS-AC (HeartLight)
Pulmonary vien isolation
Control Arm Ablation
Treatment with standard ablation.
Eligibility Criteria
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Inclusion Criteria
* paroxysmal atrial fibrillation
* failure of at least one AAD
* others
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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CardioFocus
INDUSTRY
Responsible Party
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Principal Investigators
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Burke Barrett
Role: STUDY_DIRECTOR
CardioFocus, Inc. (sponsor)
Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
Mt. Sinai Hospital, NYC
Andrea Natale, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Research Foundation
Locations
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University of Alabama, Birmingham
Birminham, Alabama, United States
Stanford Hospital
Palo Alto, California, United States
Regional Cardiology Associates, Mercy General Hospital
Sacramento, California, United States
UCSF
San Francisco, California, United States
Pacific Heart Institute
Santa Monica, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Prairie Heart Institute
Springfield, Illinois, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Mayo Clinic Rochester/St. Mary's Hospital
Rochester, Minnesota, United States
Mt. Sinai Hospital
New York, New York, United States
Duke University
Durham, North Carolina, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University South Carolina
Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Countries
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References
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Dukkipati SR, Cuoco F, Kutinsky I, Aryana A, Bahnson TD, Lakkireddy D, Woollett I, Issa ZF, Natale A, Reddy VY; HeartLight Study Investigators. Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation. J Am Coll Cardiol. 2015 Sep 22;66(12):1350-60. doi: 10.1016/j.jacc.2015.07.036.
Other Identifiers
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25-3002
Identifier Type: -
Identifier Source: org_study_id
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