ProMRI (Phase C)

ProMRI

Phase C

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

Study Design

  • Prospective, single-arm, non-randomized, multicenter
  • To 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: 100% free of MRI and pacing system related serious adverse device effects1


Key Result 2

Ventricular pacing threshold: 100% of patients experienced


Key Result 3

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
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 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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ProMRI

PROMRI

ProMRI Technology: Safe MRI access for cardiac device patients.


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.