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3T MRI CIED Post-Approval Study

NCT02969395 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2022-08-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).

Conditions

  • Cardiac Rhythm Disorder

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-10-15
Completion
2021-10-15

Countries

  • United States
  • Belgium
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Portugal
  • Serbia
  • Slovakia
  • Slovenia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02969395 on ClinicalTrials.gov