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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175797
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
MicroPort CRM

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.

Condition or disease Intervention/treatment Phase
Bradycardia Device: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175797


Locations
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France
CHU Charles Nicolle
Rouen, France, 76000
Sponsors and Collaborators
MicroPort CRM
Investigators
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Principal Investigator: Arnaud Mr SAVOURE, cardiologist CHU Charles Nicolle - 1 rue Germont, 76000 ROUEN
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Responsible Party: MicroPort CRM
ClinicalTrials.gov Identifier: NCT02175797    
Other Study ID Numbers: IBMR02 - IKONE
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Keywords provided by MicroPort CRM:
Pacemaker, leads and MRI exam
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes