ProMRI (Phase B)

ProMRI (Phase B)

Clinical Safety of the ProMRI Pacemaker System when Used Under Specific MRI Conditions without Scan Exclusion Zone

Bailey, Heart Rhythm 2016

Study Design

  • Prospective, single-arm, non-randomized, multicenter study
  • Demonstrate the clinical safety of the ProMRI pacemaker system when used under specific MRI conditions
  • 245 patients at 31 centers in USA

     

Key result 1

SADE free rate: 99.6% free of MRI and pacing system related serious adverse device effects1


Key Result 2

Atrial pacing threshold: 100% of patients experienced 1


Key Result 3

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

P-wave sensing attenuation: 98.2% 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 — 100% 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

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 ventricular pacing threshold rise
  • Percentage of participants free of P-wave sensing attenuation
  • Percentage of participants free of R-wave sensing attenuation
Clinical Sites
  • 31 centers in USA
Sample Size
  • 245 patients
Main 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
  • December 2013 - January 2015
Reference no.
  • NCT02009696

Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions


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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.