Clinical trial NCT00392106: High Intensity Focused Ultrasound (HIFU) Ablation System Study
Official title: Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
arrhythmia
AF ablation
antiarrhythmic agent
catheter ablation
pulmonary veins
Lead sponsor: ProRhythm, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility 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

Primary outcomes:
measure: Acute treatment with elimination of AF episodes
timeFrame: 12 months
measure: Death, stroke, and hospitalization for recurrence of AF
timeFrame: within 12 months of treatment
Secondary outcomes:
measure: Acute treatment success
timeFrame: 60 days
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Fullerton Vascular Medical Group
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Lexington
country: United States
facility: Lexington Central Baptist Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hopsital
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: New York
country: United States
facility: New York University Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Winston Salem
country: United States
facility: Wake Forest University Health Systems
state: North Carolina
city: Cleveland
country: United States
facility: Hillcrest Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Heart Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Dallas
country: United States
facility: University of Texas, Southwestern
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Prague
country: Czech Republic
facility: Homolka Hospital
Study officials:
affiliation: Oklahoma University Health Sciences Center
name: Warren Jackman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Medical Center
name: Hugh Calkins, MD
role: PRINCIPAL_INVESTIGATOR
References: