NCT01218763

CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device

CANadian Clinical Evaluation of the Automatic Arrhythmia DETECTion in SpiderFlash™ Device

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 101 (estimated)
• Sponsor: Sorin Group Canada · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Arrhythmias, Cardiac

Timeline

• Start date: 2010-04-01
• First posted: 2010-10-11
• Last updated: 2011-06-13

Locations

5 sites across 1 country: Canada