Skip to main content
OpenTrials
Completed

NCT Number: NCT02175797

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Charles Nicolle

Rouen, 76000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

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

Primary outcomes

  1. Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

MicroPort CRM

Industry

Registry information

Acronym: IKONE

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2014
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.