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).

Study Overview

• Status: Completed
• Conditions: Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted

• Study Type: Observational
• Enrollment (Actual): 2067

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with ProMRI CIED implanted，including ProMRI Pacemaker/CRT and ProMRI ICD/CRTD

Description

1. 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

2. 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serious adverse events	two years
The raise of Impedance Threshold of the Atrial and Ventricle	immediate；one month
RA sensing amplitude (daily mean): < 1.5 mV or RV sensing amplitude (daily min.): < 2.0 mV	immediate；one month
The proportion of patients with CIED who need MRI examination	two years

Collaborators and Investigators

• Sponsor: Biotronik (Beijing) Medical Device Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2015
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2015-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No