Clinical Trial TitleSafety and Effectiveness IDE trial for Boston Scientific’s Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation (FROzEN AF)
National Clinical Trial Number:NCT04133168
Clinical Trial Protocol Description:
The purpose of this study is to evaluate the safety and effectiveness (success) of the POLARxTM Cryoablation System for the treatment of symptomatic, recurrent, paroxysmal atrial fibrillation. This study will be conducted at up to 50 sites throughout the United States, Canada and Asia Pacific. Globally, 405 patients will be recruited for this study. At Rush University Medical, we expect to recruit approximately 15 patients. All subjects enrolled will undergo a Cryoablation procedure using Boston Scientific’s POLARxTM Cryoablation System.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have been diagnosed with symptomatic, paroxysmal atrial fibrillation.
- Have been indicated for ablation procedure.
- Have no amiodarone use for 90 days.
- Are refractory or intolerant to at least one class I or III antiarrhythmic medication.
You will be excluded from the study if any of the following criteria apply to you:
- Have a BMI >40.
- Are >75 years of age.
- Have continuous atrial fibrillation lasting longer than 7 days.
- Are contraindicated for an ablation procedure.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.