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POLARx Post Approval Study (POLARx PAS)
Sponsor: Boston Scientific Corporation
Summary
To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of de novo Atrial Fibrillation (AF).
Official title: Prospective Multi-Site Safety and Effectiveness Study of the Boston Scientific Cardiac Cryoablation System for Drug Refractory, Recurrent Symptomatic Paroxysmal Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-06-28
Completion Date
2029-05
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
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
Locations (11)
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Pima Heart & Vascular Clinical Research
Tucson, Arizona, United States
Torrance Memorial Medical Center
Torrance, California, United States
Intermountain Platte Valley Hospital
Brighton, Colorado, United States
Valley View Hospital
Glenwood Springs, Colorado, United States
St. Joseph's Hospital/BayCare Medical Group
Tampa, Florida, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
University of Texas Medical Branch - Galveston
Galveston, Texas, United States
Aurora Health
Grafton, Wisconsin, United States