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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00392106
Other study ID # CLIN-003
Secondary ID
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


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
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