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Registry Study of Clinical Ap...

Registry Study of Clinical Application of MRI Compatible CIED

Last Updated: 2022-08-17

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

Total Enrollment

2067 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-15

Study Completion Date

2020-09-30

Brief Summary

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The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).

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Detailed Description

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Conditions

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Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient is \>18 years old
* Patient implanted with a Biotronik MRI compatible CIED (including the pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and cardiac resynchronization therapy-defibrillator) in the past two months
* Patient has provided a written informed consent
* Patient's height is≥140cm

Exclusion Criteria

* Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
* Life expectancy less than 2 years
* Pregnant and/or breat-feeding females or females who intend to become pregnant in next two years
* Patient is currently participating in another study
* In the investigator's opinion patient will not be able to comply with the follow-up requirements

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers