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Clinical Trial Summary

The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04198701
Study type Interventional
Source Medtronic Cardiac Rhythm and Heart Failure
Contact
Status Completed
Phase N/A
Start date December 10, 2019
Completion date November 28, 2022

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