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High Intensity Focused Ultrasound (HIFU) Ablation System Study

Information source: ProRhythm, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: propafenone (Drug); flecainide (Drug); dofetilide (Drug); sotolol (Drug); Pulmonary vein ablation (Device); Amiodarone (Drug)

Phase: Phase 3

Status: Suspended

Sponsored by: ProRhythm, Inc.

Official(s) and/or principal investigator(s):
Warren Jackman, MD, Principal Investigator, Affiliation: Oklahoma University Health Sciences Center
Hugh Calkins, MD, Principal Investigator, Affiliation: Johns Hopkins Medical Center

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.

Clinical Details

Official title: Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Acute treatment with elimination of AF episodes

Death, stroke, and hospitalization for recurrence of AF

Secondary outcome: Acute treatment success

Detailed 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).

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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 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

Locations and Contacts

Homolka Hospital, Prague, Czech Republic

Fullerton Vascular Medical Group, Fullerton, California 92835, United States

University of California, Los Angeles, Los Angeles, California 90095, United States

Piedmont Hospital, Atlanta, Georgia 30309, United States

Lexington Central Baptist Hospital, Lexington, Kentucky 40503, United States

Johns Hopkins Hopsital, Baltimore, Maryland 21287, United States

Lahey Clinic, Burlington, Massachusetts 01805, United States

Beaumont Hospital, Royal Oak, Michigan 48220, United States

New York University Hospital, New York, New York 10016, United States

Stony Brook University Hospital, Stony Brook, New York 11794, United States

Wake Forest University Health Systems, Winston Salem, North Carolina 27157, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Hillcrest Hospital, Cleveland, Ohio 44124, United States

The Ohio State University Heart Center, Columbus, Ohio 43210, United States

Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Texas Cardiac Arrhythmia Research, Austin, Texas 78705, United States

University of Texas, Southwestern, Dallas, Texas 75390, United States

University of Virginia, Charlottesville, Virginia 22903, United States

Sentara Norfolk General Hospital, Norfolk, Virginia 23507, United States

Additional Information

Starting date: April 2006
Last updated: June 16, 2008

Page last updated: August 23, 2015

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