High Intensity Focused Ultrasound (HIFU) Ablation System Study

June 16, 2008 updated by: ProRhythm, Inc.

Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic
        • Homolka Hospital
  • United States
    • California
      • Fullerton, California, United States, 92835
        • Fullerton Vascular Medical Group
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Lexington Central Baptist Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hopsital
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • Michigan
      • Royal Oak, Michigan, United States, 48220
        • Beaumont Hospital
    • New York
      • New York, New York, United States, 10016
        • New York University Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Wake Forest University Health Systems
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44124
        • Hillcrest Hospital
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Heart Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research
      • Dallas, Texas, United States, 75390
        • University of Texas, Southwestern
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Class I or III anti-arrhythmic drug for the treatment of AF
Drug: propafenone
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
Other Names:
  • Rhyhmol
Drug: flecainide
Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation
Other Names:
  • Tambocor
Drug: dofetilide
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
Other Names:
  • Tikosyn
Drug: sotolol
Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation
Other Names:
  • Betapace
Drug: Amiodarone
Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation
Other Names:
  • Pacerone
Experimental: Treatment
Pulmonary vein ablation with HIFU
Device: Pulmonary vein ablation
Electrical isolation of pulmonary vein with high-intensity focused ultrasound
Other Names:
  • Left atrial ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute treatment with elimination of AF episodes
Time Frame: 12 months
12 months
Death, stroke, and hospitalization for recurrence of AF
Time Frame: within 12 months of treatment
within 12 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute treatment success
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProRhythm, Inc.

Investigators

  • Principal Investigator: Warren Jackman, MD, Oklahoma University Health Sciences Center
  • Principal Investigator: Hugh Calkins, MD, Johns Hopkins Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria

October 24, 2006

First Posted (Estimate)

October 25, 2006

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 16, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-003
  • NCT00392106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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