High Intensity Focused Ultrasound (HIFU) Ablation System Study

Paused · Phase 3

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT00392106

Run by

ProRhythm, Inc.

People needed

240

Starts

2006-04-01

Expected to finish

2011-06-01

Last updated by the study team

2008-06-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fullerton Vascular Medical Group — Fullerton, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Lexington Central Baptist Hospital — Lexington, Kentucky, United States
• Johns Hopkins Hopsital — Baltimore, Maryland, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Beaumont Hospital — Royal Oak, Michigan, United States
• New York University Hospital — New York, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Wake Forest University Health Systems — Winston-Salem, North Carolina, United States
• Hillcrest Hospital — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University Heart Center — Columbus, Ohio, United States
• Oklahoma University Health Sciences Center — Oklahoma City, Oklahoma, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Cardiac Arrhythmia Research — Austin, Texas, United States
• University of Texas, Southwestern — Dallas, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• Homolka Hospital — Prague, Czechia

Full record on ClinicalTrials.gov

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