ProMRI C

ProMRI

Phase C

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

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Study Design

  • Prospective, single-arm, non-randomized, multicenter

SADE free rate

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

Ventricular pacing threshold

100% of patients experienced

Ventricular sensing attenuation

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

Clinical Relevance

  • Data demonstrates and supports the clinical safety and efficacy of the ProMRI ICD system when used under specific MRI conditons.
Reference no.
  • NCT02096692
Study Objective
  • The objective of the ProMRI study is to demonstrate the clinical safety of the ProMRI ICD system when used under specific MRI conditions.
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-wave sensing attenuation
Clinical Sites
  • 39 US Centers
Sample Size
  • 170
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

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Tachycardia Therapy

TACHYCARDIA THERAPY

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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.