High Intensity Focused Ultrasound (HIFU) Ablation System Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: propafenone
* Drug: flecainide
* Drug: dofetilide
* Drug: sotolol
* Device: Pulmonary vein ablation
* Drug: Amiodarone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute treatment success |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, arrhythmia, AF ablation, antiarrhythmic agent, catheter ablation, pulmonary veins