NCT05282823

POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)

POLARx™ Cardiac Cryoablation System Post Market Clinical Study POLAR SMART

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 295 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)

Detailed description

The study will collect real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of De Novo Atrial Fibrillation (AF).

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Boston Scientific Cardiac Cryoablation System	is indicated for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of AF as per current and future guidelines and system IFU/ Tenpubunsyo.

Timeline

• Start date: 2022-08-26
• Primary completion: 2024-10-29
• Completion: 2024-10-29
• First posted: 2022-03-16
• Last updated: 2025-12-02
• Results posted: 2025-12-02

Locations

19 sites across 2 countries: Japan, South Korea