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CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device

NCT01218763 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2011-06-13

No results posted yet for this study

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

Sponsors & Collaborators

  • Sorin Group Canada

    lead INDUSTRY

Principal Investigators

  • Marcio Sturmer, MD · Hopital du Sacre-Coeur, Montreal, Qc, Canada

  • Bernard Thibault, MD · MHI, Montreal, Qc, Canada

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218763 on ClinicalTrials.gov