Cardiac Arrhythmia Clinical Trial
Official title:
A Clinical Evaluation Using EnSite Precision Cardiac Mapping System (Software Version 2.0.1 or Higher) in a Real-World Environment
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational
Study.
This clinical study is intended to quantify and characterize the usage of the EnSite
Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world
environment. This study will be conducted in patients who are indicated for a cardiac
electrophysiological (EP) mapping and radio frequency ablation procedure using a
three-dimensional system.
The EnSite Precision™ Cardiac Mapping System is a newly developed system that introduces
features such as Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) image integration,
lesion marking automaticity, automatic mapping, and workflow flexibility to aid in the
success of complex ablation procedures. Utilization of this system in the treatment of
complex ablation procedures and its impact on patient outcomes is not well characterized.
This clinical study is designed to collect a broad range of usage scenarios, therefore this
clinical study has limited patient selection criteria and data collection is focused on
EnSite Precision™ Cardiac Mapping System usage and patient outcomes.
The data collected from the procedure (performed per Instructions For Use (IFU) and per
standard practice of the physician) as well as the 12 month follow up period enables the
Sponsor to review the system's standard practice usage. This information will be added to the
current knowledge and understanding of treatment options for patients with arrhythmias, which
can assist the Sponsor to provide future recommendations for best practices to improve
patient outcomes.
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