Focused Circumferential Ultrasound for the Treatment of Atrial Fibrillation

Study Long Title:

IRB Number:

To assess the safety and effectiveness of the ProRhythm HIFU PV System for the treatment of patients with symptomatic Paroxysmal Atrial Fibrillation (PAF) who have failed or are intolerant to Class I or III anti-arrhythmic drugs (AADs).

The HIFU PV catheter focuses ultrasound waves to ablate circumferential lesions outside the ostia of the pulmonary veins.

Inclusions:

Symptomatic PAF with at least 2 AF episodes within past 6 months

Failed or intolerant to at least 2 class I or III AADs

Patients taking Amiodarone or other not-approved AADs must also have failed Class I or III AADs

Must be able to tolerate one approved Class I or III AAD

Exclusions:

Persistent or chronic AF

Mitral disease

Ejection fraction <40%

History of stroke

Severe left ventricular hypertrophy

Pulmonary disease

Esophageal disease

Clinical Trial Site: