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Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Banner University Medical Center
Phoenix, Arizona, United States
Pima Heart and Vascular
Tucson, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Cedars - Sinai Medical Center
Los Angeles, California, United States
Mercy General Hospital
Sacramento, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
St. Joseph's Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Start Date
June 24, 2020
Primary Completion Date
November 10, 2022
Completion Date
August 17, 2023
Last Updated
April 3, 2025
458
ACTUAL participants
Boston Scientific Cardiac Cryoablation System
DEVICE
Lead Sponsor
Boston Scientific Corporation
NCT07281898
NCT06765356
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06106594