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Clinical Trial Summary

This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.


Clinical Trial Description

The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01639495
Study type Interventional
Source Biosense Webster, Inc.
Contact
Status Completed
Phase Phase 3
Start date July 1, 2012
Completion date October 1, 2014