High Intensity Focused Ultrasound (HIFU) Ablation System Study

Atrial Fibrillation Clinical Trial

Official title:

Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00392106
• Other study ID #: CLIN-003
• Status: Suspended
• Phase: Phase 3
• First received: October 24, 2006
• Last updated: June 16, 2008
• Start date: April 2006
• Est. completion date: June 2011

Study information

• Verified date: June 2008
• Source: ProRhythm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 240
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• propafenone
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
• flecainide
Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation
• dofetilide
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
• sotolol
Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation

Device:
• Pulmonary vein ablation
Electrical isolation of pulmonary vein with high-intensity focused ultrasound

Drug:
• Amiodarone
Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ProRhythm, Inc.

Countries where clinical trial is conducted

United States,  Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute treatment with elimination of AF episodes		12 months	No
Primary	Death, stroke, and hospitalization for recurrence of AF		within 12 months of treatment	Yes
Secondary	Acute treatment success		60 days	No