ProMRI (Phase C)

ProMRI (Phase C)

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

Awad, Heart Rhythm 2015

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Study Design

  • Prospective, single-arm, non-randomized, multicenter study
  • Demonstrates the clinical safety of the ProMRI ICD system when used under specific MRI conditions
  • 170 patients at 39 centers in USA

Key result 1

SADE free rate: 100% free of MRI and pacing system related serious adverse device effects1

Key Result 2

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

Key Result 3

Ventricular sensing attenuation: 99.3% of patients experienced < 50% R-wave sensing attenuation1

Clinical Relevance

  • The data demonstrate and support the clinical safety and efficacy of the ProMRI ICD system when used under specific MRI conditons
1° Endpoints
  • MRI and ICD system related serious adverse device effect (SADE) free rate
  • Percentage of participants free of ventricular pacing threshold rise
  • Percentage of participants free of R-waves ensing attenuation
Clinical Sites
  • 39 centers in USA
Sample Size
  • 170 patients enrolled
Inclusion Criteria
  • Implanted with an ICD system consisting only of an Iforia DR-T and Linoxsmart S 65 / Linoxsmart SD 65/18 with Setrox S 53 atrial lead or Iforia VR-T DX and Linoxsmart S DX 65/15 or Linoxsmart S DX 65/17.
  • Patients with measureable pacing thresholds greater than or equal to 2.0 V @ 0.4 ms
  • Patients withICD implanted at least 6 weeks prior to MRI procedure
Main Exclusion Criteria
  • Patients implanted with other medical devices that may interact with MRI
Devices
  • Iforia DR-T and Linoxsmart S 65 / Linoxsmart SD 65/18 with Setrox S 53 atrial lead or Iforia VR-T DX and Linoxsmart S DX 65/15 or Linoxsmart S DX 65/17
Follow-Up
  • Three months post-MRI
Study Duration
  • June 2014 - June 2015
Reference no.
  • NCT02096692

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Clinical safety of the Iforia implantable cardioverter-defibrillator system
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1 Awad K, Griffin J, Crawford TC, Cox SL, Ferrick K, Mazur A, Pena RE, Lloyd SG, Michalski J, Johnson W, Bailey WM, on behalf of ProMRI Investigators. Clinical safety of the Iforia implantable cardioverter-defibrillator system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm 12.10 (2015): 2155-2161.