THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

Last updated: January 31, 2025
Sponsor: Biosense Webster, Inc.
Overall Status: Completed

Phase

3

Condition

Cardiac Disease

Chest Pain

Arrhythmia

Treatment

THERMOCOOL® SMARTTOUCH™ Catheter

Clinical Study ID

NCT01385202
Smart-AF
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have had at least 3 atrial fibrillation episodes within 6 months of this study

  • Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillationepisodes

  • 18 years of age or older

Exclusion

Exclusion Criteria:

  • Have had previous ablation for atrial fibrillation

  • Have take amiodarone within 6 months of this study

  • Have had any heart surgery within the last 60 days

  • Have had a heart attack within the last 60 days

  • Females who are pregnant or breast feeding

Study Design

Total Participants: 172
Treatment Group(s): 1
Primary Treatment: THERMOCOOL® SMARTTOUCH™ Catheter
Phase: 3
Study Start date:
June 01, 2011
Estimated Completion Date:
May 31, 2013

Connect with a study center

  • University of Alabama, Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Stanford University School of Medicine

    Stanford, California 94305
    United States

    Site Not Available

  • Florida Hospital

    Orlando, Florida 32803
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Loyola University Chicago

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Kansas Hospitals

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Park Nicollet Institute

    Minneapolis, Minnesota 55416
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • The Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas 78705
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23219
    United States

    Site Not Available

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