Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-25 @ 3:07 PM
NCT ID:
NCT04133168
Group ID:
EG000
Title:
FROzEN Non Roll In Treatment and Attempt Subjects
Description:
Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System
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
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
33
Serious Number At Risk:
326
Other Number Affected:
86
Other Number At Risk:
326
Study:
NCT04133168
Results Section:
NCT04133168
Adverse Events Module:
NCT04133168