STOP Persistent AF PAS

Status Recruiting

Clinical Trial Summary

The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.

Clinical Trial Description

The STOP Persistent AF Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The PAS is a prospective, global, multicenter, observational trial. The purpose of the PAS is to describe long-term clinical performance and safety data in the Persistent AF population treated with Arctic Front™ and Freezor™ MAX Families of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System). This PAS is a condition of the Pre-Market Approval order (P100010/S098) by the U.S. Food and Drug Administration. Up to 400 subjects will be enrolled to ensure 355 are treated. A minimum of 50% of patients will be enrolled and treated in the US. The follow-up duration for this post-approval study will be 36-months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05005949
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	August 19, 2021
Completion date	August 2027

View Details

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