NCT04133168

Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

Detailed description

Multi-center, open label, prospective, single arm study to document the safety and performance of Boston Scientific's Cryoablation System. The Cryoablation System is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF). All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for twelve (12) months after the index procedure.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Boston Scientific Cardiac Cryoablation System	The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following: * POLARx™ or POLARx™ FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories

Timeline

• Start date: 2020-06-24
• Primary completion: 2022-11-10
• Completion: 2023-08-17
• First posted: 2019-10-21
• Last updated: 2025-04-03
• Results posted: 2023-12-07

Locations

44 sites across 9 countries: United States, Belgium, Canada, France, Germany, Hong Kong, Italy, Netherlands, Taiwan

Regulatory

• FDA-regulated device study