NCT05227053

STOP AF First Post-Approval Study

STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Arctic Front™ Cardiac Cryoablation Catheter	Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system

Timeline

• Start date: 2022-04-28
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2022-02-07
• Last updated: 2025-11-14

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study