Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
(FROZEN-AF Trial)
Recruiting in Palo Alto (17 mi)
+43 other locations
Overseen ByNiraj Varma, MD, PhD, FRCP
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Boston Scientific Corporation
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a device that uses extreme cold to treat patients with a specific type of irregular heartbeat that doesn't improve with medication. The device works by freezing the veins in the heart that cause the problem.
Eligibility Criteria
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CryoablationExperimental Treatment1 Intervention
Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System
Boston Scientific Cardiac Cryoablation System is already approved in European Union, United States, Japan, Canada for the following indications:
🇪🇺 Approved in European Union as POLARx Cryoablation System for:
- Paroxysmal Atrial Fibrillation (AF)
🇺🇸 Approved in United States as POLARx Cryoablation System for:
- Paroxysmal Atrial Fibrillation (AF)
🇯🇵 Approved in Japan as POLARx Cryoablation System for:
- Paroxysmal Atrial Fibrillation (AF)
🇨🇦 Approved in Canada as POLARx Cryoablation System for:
- Paroxysmal Atrial Fibrillation (AF)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
St. Mary's Medical CenterHuntington, WV
Aurora Health CareGrafton, WI
Institut universitaire de Cardiologie et de Pneumologie de QuebecQuebec, Canada
Vancouver General HospitalVancouver, Canada
More Trial Locations
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Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor