NCT02380300

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,067

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

March 15, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

5.5 years

First QC Date

March 2, 2015

Last Update Submit

August 15, 2022

Conditions

Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted

Outcome Measures

Primary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 5, 2015

Study Start

March 15, 2015

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

August 17, 2022

Record last verified: 2022-08