STOP AF First Post-Approval Study

Status Recruiting

Clinical Trial Summary

The STOP AF First PAS is a prospective, global, multi-center, observational trial.

Clinical Trial Description

The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05227053
Study type	Observational
Source	Medtronic Cardiac Rhythm and Heart Failure
Contact	Ryan Radtke
Phone	712.941.9372
Email	ryan.s.radtke@medtronic.com
Status	Recruiting
Phase
Start date	April 28, 2022
Completion date	January 2028

View Details

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