Trial | NCT00392106  Report issue

Title

High Intensity Focused Ultrasound (HIFU) Ablation System Study
Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Suspended

  • Study Participants

    240
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.
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 Started
Apr 30
2006
Primary Completion
Dec 31
2010
Anticipated
Study Completion
Jun 30
2011
Anticipated
Last Update
Jun 17
2008
Estimate

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

Device Pulmonary vein ablation

Electrical isolation of pulmonary vein with high-intensity focused ultrasound

  • Other names: Left atrial ablation

Drug Amiodarone

Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation

  • Other names: Pacerone

Control Active Comparator

Class I or III anti-arrhythmic drug for the treatment of AF

Treatment Experimental

Pulmonary vein ablation with HIFU

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
No Results Posted