High Intensity Focused Ultrasound (HIFU) Ablation System Study

Last updated: June 16, 2008
Sponsor: ProRhythm, Inc.
Overall Status: Suspended

Phase

3

Condition

Chest Pain

Arrhythmia

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT00392106
CLIN-003
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented atrial fibrillation

  • Failed or intolerant to at least 1 anti-arrhythmic drug

  • Able to take anti-coagulant therapy

  • Able to complete screening tests required for inclusion/exclusion criteria

  • Able to take at least 1 approved anti-arrhythmic drug

  • Not pregnant

  • Available for follow-up for at least 12 months

Exclusion

Exclusion Criteria:

  • Persistent or permanent atrial fibrillation

  • Mitral disease

  • Prior surgical treatment for atrial fibrillation

  • Ablation for treatment of atrial fibrillation within 6 months

  • Severe left ventricular hypertrophy

  • Known untreated coagulopathy

  • Unstable angina

  • Prior stroke

  • Uncontrolled heart failure

  • Secondary causes of atrial fibrillation

  • Uncorrected hyperthyroidism within 12 months

  • Pulmonary embolism within 6 months

  • Pneumonia or acute pulmonary disease within 3 months

  • Pacemaker/ICD

  • High risk for esophageal disease

  • Currently enrolled in investigational drug or device study

Study Design

Total Participants: 240
Study Start date:
April 01, 2006
Estimated Completion Date:
June 30, 2011

Study Description

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia affecting an estimated 2.2 million persons in the United States (US). In addition to being debilitating, AF has been identified as a leading risk factor for stroke. AF is often associated with structural heart disease, but a substantial number of AF patients have little or no detectable structural heart disease. A patient with AF is up to 5 times more likely to have a stroke than the general population.

Recently, it has been demonstrated that for a significant portion of AF patients (80% - 95 %) the arrhythmia originates in one of the four pulmonary veins (PV's). Furthermore, it has been shown that isolation of this arrhythmia by ablation can, in the majority of patients (50-70%), eliminate or markedly reduce episodes of AF. Currently, there are a number of modalities being investigated to treat AF. They include radiofrequency, laser, thermal, cryo, microwave, and ultrasound ablation of targeted areas in the atrium and/or PVs.

Comparison(s): Clinical success of High Intensity Focused Ultrasound (HIFU) Ablation for Pulmonary Vein Isolation in the treatment of Atrial Fibrillation, compared to medical therapy with anti-arrhythmic drugs (AADs).

Connect with a study center

  • Homolka Hospital

    Prague,
    Czech Republic

    Site Not Available

  • Fullerton Vascular Medical Group

    Fullerton, California 92835
    United States

    Site Not Available

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Piedmont Hospital

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Lexington Central Baptist Hospital

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Johns Hopkins Hopsital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Lahey Clinic

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Beaumont Hospital

    Royal Oak, Michigan 48220
    United States

    Site Not Available

  • New York University Hospital

    New York, New York 10016
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Wake Forest University Health Systems

    Winston Salem, North Carolina 27157
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Hillcrest Hospital

    Cleveland, Ohio 44124
    United States

    Site Not Available

  • The Ohio State University Heart Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research

    Austin, Texas 78705
    United States

    Site Not Available

  • University of Texas, Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

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