Arrhythmias, Cardiac Clinical Trial
Official title:
CANadian Clinical Evaluation of the Automatic Arrhythmia DETECTion in SpiderFlash™ Device
This clinical investigation is a prospective, non-randomized, multi-center pivotal trial.
This trial aims to validate the automatic detection features provided by the external
long-duration SpiderFlash-t™ Event recorder coupled with its analyser EventScope™, and to
assess the performances of the Mode Switch function provided by Sorin Group Implantable
Cardioverter-Defibrillators (ICDs).
This trial is being performed first in order to demonstrate the ventricular tachycardia
(VT)/ ventricular fibrillation (VF) sensitivity of the automatic VT/VF detection function of
the EventScope™ software.
Patients will be implanted with an ICD from Sorin Group, with PARAD+ arrhythmia detection
enabled and Mode Switch (MS) algorithms activated in all patients.
Arrhythmic events will be documented over a period of 6 to 8 weeks for each patient.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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