ProMRI (Phase B)
Clinical Safety of the ProMRI Pacemaker System when Used Under Specific MRI Conditions without Scan Exclusion Zone
Bailey, Heart Rhythm 2016
- 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
- The data demonstrate and support the clinical safety and efficacy of the ProMRI pacemaker system when used under specific MRI conditons
|Main Inclusion Criteria|
|Main Exclusion Criteria|
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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ProMRI Technology: Safe MRI access for cardiac device patients.
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.