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

Outcome

Outcome not reported

Stopped: “voluntarily by Sponsor to investigate an anticipated SAE”

Drugs

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

Indications