The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
17
Cryoablation
BayCare Medical Group Cardiology
Tampa, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Montreal Heart Institute
Montreal, Quebec, Canada
Number of Participants With Primary Safety Events With an Onset Date Within 7 Days Post-procedure.
A primary safety event is defined as: An ArcticLine Catheter-related or ArcticLine cryoablation procedure-related SAE with an onset date within 7 days post-procedure (except as noted below), as adjudicated by the Clinical Events Committee (CEC), described as follows: * Atrioesophageal fistula\* \* Includes atrioesophageal fistula with an onset date at any time after the study cryoablation procedure and is adjudicated by the CEC as either ArcticLine Catheter-related or ArcticLine cryoablation procedure-related. * Cardiac perforation/tamponade * Cerebrovascular accident * Death * Esophageal injury * Major bleeding * Myocardial infarction * Pericarditis * Phrenic nerve injury (ongoing at hospital discharge) * Transient ischemic attack * Vagal nerve injury resulting in esophageal dysmotility or gastroparesis * Vascular access complications
Time frame: 7 days
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