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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bradycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pacemaker + leads

all patients must have a MRI exam after pacemaker implantation

Group Type OTHER

MRI

Intervention Type DEVICE

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

Interventions

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MRI

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No