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

Primary Purpose

Bradycardia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
MicroPort CRM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bradycardia focused on measuring Pacemaker, leads and MRI exam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Charles Nicolle

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pacemaker + leads

Arm Description

all patients must have a MRI exam after pacemaker implantation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 4, 2014
Last Updated
April 19, 2019
Sponsor
MicroPort CRM
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1. Study Identification

Unique Protocol Identification Number
NCT02175797
Brief Title
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
Acronym
IKONE
Official Title
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort CRM

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
Keywords
Pacemaker, leads and MRI exam

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pacemaker + leads
Arm Type
Other
Arm Description
all patients must have a MRI exam after pacemaker implantation
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
at least 6 weeks after the implantation of the pacemaker a MRI exam is performed
Primary Outcome Measure Information:
Title
Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Mr SAVOURE, cardiologist
Organizational Affiliation
CHU Charles Nicolle - 1 rue Germont, 76000 ROUEN
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

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

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