458
Participants
Start Date
June 24, 2020
Primary Completion Date
November 10, 2022
Study Completion Date
August 17, 2023
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"
National Taiwan University Hospital, Taipei
Mount Sinai Medical Center, New York
Northwell Health, Staten Island
Taipei Veterans General Hospital, Taipei
St. Joseph's Hospital Health Center, Syracuse
University of Pittsburgh Medical Center, Pittsburgh
York Hospital, York
Chippenham & Johnston-Willis Hospital, Richmond
Virginia Commonwealth University Health System, Richmond
St. Mary's Medical Center, Huntington
Emory University Hospital, Atlanta
Tallahassee Memorial Hospital, Tallahassee
AdventHealth Tampa, Tampa
St. Joseph's Hospital, Tampa
Vanderbilt University Medical Center, Nashville
CHU Grenoble - Hopital Michallon, Grenoble
Stern Cardiovascular Foundation, Inc., Germantown
Cleveland Clinic Foundation, Cleveland
Kettering Medical Center, Kettering
Aurora Health Care, Grafton
Rush University Medical Center, Chicago
St. Luke's Hospital of Kansas City, Kansas City
Arrhythmia Research Group, Jonesboro
Baylor Heart & Vascular Hospital, Dallas
Christus Trinity Mother Frances Health System, Tyler
Banner University Medical Center, Phoenix
Pima Heart and Vascular, Tucson
Cedars - Sinai Medical Center, Los Angeles
Torrance Memorial Medical Center, Torrance
Mercy General Hospital, Sacramento
PeaceHealth Southwest Medical, Vancouver
Southcoast Physicians Group, Fall River
Valley Hospital, Ridgewood
UZ Brussels, Brussels
Institut de Cardiologie de Montreal, Montreal
Vancouver General Hospital, Vancouver
Herz-und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
Queen Mary Hospital, Hong Kong
Prince of Wales Hospital, Shatin
Maria Cecilia Hospital SPA, Cotignola
Hamilton General Hospital, Hamilton
Institut universitaire de Cardiologie et de Pneumologie de Quebec, Québec
Universitaetsklinikum Schleswig-Holstein, Lübeck
Erasmus MC- University Medical Center Rotterdam, Rotterdam
Lead Sponsor
Boston Scientific Corporation
INDUSTRY