NCT05005949

STOP Persistent AF PAS

STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Arctic Front™ Cardiac Cryoablation Catheter System	Pulmonary vein isolation will be performed with the Arctic Front™ Cardiac Cryoablation Catheter System

Timeline

• Start date: 2021-08-19
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2021-08-16
• Last updated: 2025-11-13

Locations

17 sites across 6 countries: United States, Austria, Germany, Italy, Poland, United Kingdom

Regulatory

• FDA-regulated device study