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Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation — FROZEN-AF  

Paroxysmal Atrial Fibrillation Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04133168
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date June 24, 2020
Completion date August 17, 2023
View Details
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