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Clinical Trials/NCT02380300
NCT02380300
Completed
Not Applicable

Registry Study of Clinical Application of MRI Compatible CIED

Biotronik (Beijing) Medical Device Ltd.0 sites2,067 target enrollmentMarch 15, 2015
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ConditionsNeed for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
Sponsor
Biotronik (Beijing) Medical Device Ltd.
Enrollment
2067
Primary Endpoint
Serious adverse events
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
March 15, 2015
End Date
September 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Biotronik (Beijing) Medical Device Ltd.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Serious adverse events

Time Frame: two years

RA sensing amplitude (daily mean): < 1.5 mV or RV sensing amplitude (daily min.): < 2.0 mV

Time Frame: immediate；one month

The proportion of patients with CIED who need MRI examination

Time Frame: two years

The raise of Impedance Threshold of the Atrial and Ventricle

Time Frame: immediate；one month

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