| Principal Investigator Name: | Hugh G. Calkins, M.D. | |
| Study Coordinator Name: | Elizabeth Robinson, R.N. | |
| Contact Phone: Study Coordinator | (410) 502 - 0517 | |
| Contact E-mail: Study Coordinator | erobin26@jhmi.edu | |
| Study Short Title: | ProRhythm FOCUS-AF | |
Study Long Title: | Focused Circumferential Ultrasound for the Treatment of Atrial Fibrillation | |
IRB Number: | JH-eIRB #NA_00003049 | |
| Funding Source: | ProRhythm (sponsor) | |
| Summary of Trial: | 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: | Johns Hopkins University 600 N. Wolfe Street, Carnegie 586 Baltimore, MD 21287 | |
| Compensation for Participating? | No, but there is a small reimbursement for the time involved in the follow-up procedures. | |
| Start Date: | 2006 | |
| Anticipated End Date: | 2010 |
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