High Intensity Focused Ultrasound (HIFU) Ablation System Study - Full Text View

Sponsor:	ProRhythm, Inc.
Information provided by:	ProRhythm, Inc.
ClinicalTrials.gov Identifier:	NCT00392106

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: propafenone Drug: flecainide Drug: dofetilide Drug: sotolol Device: Pulmonary vein ablation Drug: Amiodarone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Ultrasound

Drug Information available for: Amiodarone hydrochloride Propafenone hydrochloride Propafenone Flecainide Flecainide acetate Amidox Dofetilide Amiodarone

U.S. FDA Resources

Further study details as provided by ProRhythm, Inc.:

Primary Outcome Measures:

Acute treatment with elimination of AF episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Death, stroke, and hospitalization for recurrence of AF [ Time Frame: within 12 months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Acute treatment success [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Control Class I or III anti-arrhythmic drug for the treatment of AF	Drug: propafenone Anti-arrhythmic drug prescribed for treatment of atrial fibrillation Other Name: Rhyhmol Drug: flecainide Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation Other Name: Tambocor Drug: dofetilide Anti-arrhythmic drug prescribed for treatment of atrial fibrillation Other Name: Tikosyn Drug: sotolol Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation Other Name: Betapace Drug: Amiodarone Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation Other Name: Pacerone
Experimental: Treatment Pulmonary vein ablation with HIFU	Device: Pulmonary vein ablation Electrical isolation of pulmonary vein with high-intensity focused ultrasound Other Name: Left atrial ablation

Arms

Assigned Interventions

Active Comparator: Control

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

Drug: propafenone

Anti-arrhythmic drug prescribed for treatment of atrial fibrillation

Other Name: Rhyhmol

Drug: flecainide

Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation

Other Name: Tambocor

Drug: dofetilide

Anti-arrhythmic drug prescribed for treatment of atrial fibrillation

Other Name: Tikosyn

Drug: sotolol

Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation

Other Name: Betapace

Drug: Amiodarone

Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation

Other Name: Pacerone

Experimental: Treatment

Pulmonary vein ablation with HIFU

Device: Pulmonary vein ablation

Electrical isolation of pulmonary vein with high-intensity focused ultrasound

Other Name: Left atrial ablation

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392106

Show 21 Study Locations

Sponsors and Collaborators

ProRhythm, Inc.

Investigators

Principal Investigator:	Warren Jackman, MD	Oklahoma University Health Sciences Center
Principal Investigator:	Hugh Calkins, MD	Johns Hopkins Medical Center

More Information

No publications provided

Responsible Party:	Reinhard Warnking, President and CEO, ProRhythm, Inc.
ClinicalTrials.gov Identifier:	NCT00392106 History of Changes
Other Study ID Numbers:	CLIN-003
Study First Received:	October 24, 2006
Last Updated:	June 16, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by ProRhythm, Inc.:

atrial fibrillation
arrhythmia
AF ablation

antiarrhythmic agent
catheter ablation
pulmonary veins

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dofetilide
Amiodarone
Anti-Arrhythmia Agents
Propafenone

Flecainide
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on February 12, 2012