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Clinical Trial Summary

The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.


Clinical Trial Description

A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01456000
Study type Interventional
Source CardioFocus
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 2012
Completion date June 2016

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