Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design
2008

Safety of MRI for Patients with New Medtronic Pacemaker

Sample size: 470 publication Evidence: moderate

Author Information

Author(s): Richard Sutton, Emanuel Kanal, Bruce L. Wilkoff, David Bello, Roger Luechinger, Inge Jenniskens, Michael Hull, Torsten Sommer

Primary Institution: St Mary's Hospital, London, UK

Hypothesis

Can the new Medtronic EnRhythm MRI SureScan pacing system be safely used during MRI scans?

Conclusion

The study aims to confirm the safety and efficacy of the new pacing system in the MRI environment.

Supporting Evidence

  • Approximately 60 million MRI scans are performed worldwide each year.
  • The new pacing system is designed to minimize risks associated with MRI.
  • The study includes a control group to assess the effects of MRI on pacing function.

Takeaway

This study is testing a new pacemaker to see if it's safe for patients to have MRI scans while using it.

Methodology

A prospective, randomized controlled, unblinded clinical trial with patients randomized to undergo MRI or not after pacemaker implantation.

Potential Biases

Potential bias due to the unblinded nature of the trial.

Limitations

The study may not account for all variables affecting MRI safety in pacemaker patients.

Participant Demographics

Patients with Class I or II indications for dual chamber pacemaker implantation.

Statistical Information

Confidence Interval

95%

Digital Object Identifier (DOI)

10.1186/1745-6215-9-68

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