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

Bradycardia Clinical Trial

— IKONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175797
• Other study ID #: IBMR02 - IKONE
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: August 2014

Study information

• Verified date: April 2019
• Source: MicroPort CRM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia

Intervention

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

Locations

Country	Name	City	State
France	CHU Charles Nicolle	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort CRM

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.		1 month