High Intensity Focused Ultrasound (HIFU) Ablation System Study

• Status: Suspended
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ProRhythm, Inc.
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Dofetilide; Flecainide; Propafenone

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