Registry Study of Clinical Application of MRI Compatible CIED

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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Key information

Conditions

Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Serious adverse events

Time frame: two years
The raise of Impedance Threshold of the Atrial and Ventricle

Time frame: immediate；one month
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

Sponsors and collaborators

Lead sponsor

Biotronik (Beijing) Medical Device Ltd.

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Mar 5, 2015
Registry last updated: Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.