drugset / Trial / NCT00392106

High Intensity Focused Ultrasound (HIFU) Ablation System Study

NCT00392106

Phase 3 Suspended 240 enrolled ProRhythm, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-04
Primary completion
2010-12
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amiodarone Small molecule
Comparator Dofetilide Small molecule
Comparator flecainide Small molecule
Comparator propafenone Unknown
Comparator sotolol Unknown

Indications