Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System

Overview

The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

Interventions

  • Device: MRI
    • at least 6 weeks after the implantation of the pacemaker a MRI exam is performed

Arms, Groups and Cohorts

  • Other: Pacemaker + leads
    • all patients must have a MRI exam after pacemaker implantation

Clinical Trial Outcome Measures

Primary Measures

  • Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.
    • Time Frame: 1 month

Participating in This Clinical Trial

Inclusion Criteria

  • Patient who is already implanted with following system KORA 100 (SR or DR) pacemaker and Beflex RF45D and/or RF46D pacing leads in the left or right pectoral region
  • Patient who is able and willing out-of-chest non medical indicated MRI scanning OR patients with planned medical indicated out of chest MRI scanning
  • Patient who fulfils MRI solutions conditions
  • Patient who provides signed and dated informed consent

Exclusion Criteria

  • Implanted or planned to be implanted non MR-compatible device or material
  • Permanent Atrial Fibrillation (for DR devices)
  • Diaphragmatic/phrenic stimulation
  • Claustrophobia
  • Incessant ventricular tachyarrhythmia
  • Inability to understand the purpose of the study or refusal to co-operate
  • Unavailability for scheduled follow-ups at the implanting centre
  • Already included in another clinical trial that could affect the results of this study
  • Patient is minor (less than 18-years old)
  • Patient is pregnant – Patient is forfeiture of freedom or under guardianship

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MicroPort CRM
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Arnaud Mr SAVOURE, cardiologist, Principal Investigator, CHU Charles Nicolle – 1 rue Germont, 76000 ROUEN

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