ProMRI (Phase C)
Clinical Safety of the ProMRI ICD System when Used Under Specific MRI Conditions without Scan Exclusion Zone
Awad, Heart Rhythm 2015
- 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
- The data demonstrate and support the clinical safety and efficacy of the ProMRI ICD system when used under specific MRI conditons
|Main Exclusion Criteria|
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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.