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

April 19, 2019 updated by: MicroPort CRM
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • CHU Charles Nicolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pacemaker + leads
all patients must have a MRI exam after pacemaker implantation
Device: MRI
at least 6 weeks after the implantation of the pacemaker a MRI exam is performed

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort CRM

Investigators

  • Principal Investigator: Arnaud Mr SAVOURE, cardiologist, CHU Charles Nicolle - 1 rue Germont, 76000 ROUEN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBMR02 - IKONE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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