ProMRI AFFIRM

ProMRI (Phase A)

Clinical Safety of the ProMRI Pacemaker System when Used Under Specific MRI Conditions with Scan Exclusion Zone

Bailey, Heart Rhythm 2016

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Study Design

  • Prospective, single-arm, non-randomized, multicenter study
  • Demonstrates the clinical safety of the ProMRI pacemaker system when used under specific MRI conditions
  • 272 patients at 37 centers in the USA and Europe

Key Result 1

SADE free rate: 100% free of MRI and pacing system related serious adverse device effects 1

Key result 2:

Atrial pacing threshold: 99% of patients experienced < 0.5 V atrial pacing threshold increase post-MRI11

Key Result 3:

Ventricular pacing threshold: 100% of patients experienced < 0.5 V ventricular pacing threshold increase post-MRI1

P-wave sensing attenuation: 100% of patients experienced P-waves above 1.5 mV — 99.4% of patients experienced < 50% P-wave sensing attenuation

R-wave sensing attenuation: 100% of patients experienced R-waves above 5 mV — 99.5% of patients experienced < 50% R-wave sensing attenuation

Clinical Relevance

  • The data demonstrate and support the clinical safety and efficacy of the ProMRI pacemaker system when used under specific MRI conditons
Study Objective
  • The objective of the ProMRI study is to demonstrate the clinical safety of the ProMRI pacemaker system when used under specific MRI conditions
1° Endpoints
  • MRI and pacing system related serious adverse device effect (SADE) free rate
  • Percentage of participants free of atrial pacing threshold rise
  • Percentage of participants free of P-wave sensing attenuation
Clinical Sites
  • 37 centers in the USA and Europe
Sample Size
  • 272 patients
Inclusion Criteria
  • Patients implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s)
  • Patients with measureable pacing thresholds greater than or equal to 2.0 V @ 0.4 ms
  • Patients with pacemakers implanted at least 6 weeks prior to MRI procedure
Main Exclusion Criteria
  • Patients implanted with other medical devices that may interact with MRI
Devices
  • Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s)
Follow-Up
  • Three months post-MRI
Study Duration
  • March 2012 - May 2014
Reference no.
  • NCT01761162
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1 Bailey WM, Mazur A, McCotter C, Woodard PK, Rosenthal L, Johnson W, Mela T; ProMRI Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2016 Feb;13(2):464-71. doi: 10.1016/j.hrthm.2015.09.021. Epub 2015 Sep 25.