An observational study in Tachyarrhythmia, sponsored by Biotronik, Inc.. Completed. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by Biotronik, Inc. · Observational
Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's enrollment of 24,249 is above the median of 149 across 208 observational studies indexed under Tachycardia.
Browse Tachycardia studies →Biotronik, Inc. is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.
Exclusion Criteria:
Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection.
Primary objectives will be analyzed once 25 subjects implanted with the ProMRI ICD system have been identified with a documented true VF episode post-MRI.
Time frame: Up to 5 years post-approval
Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI.
Time frame: Up to 5 years post-approval
Workflow compliance following MR exposure
Proportion of subjects with appropriate restoration of tachycardia detection and ICD therapy post-MRI.
Time frame: Up to 5 years post-approval
Left ventricular sensing attenuation
Proportion of subjects who experience left ventricular sensing amplitude attenuation \>50% between pre-MRI and 30 days post-MRI.
Time frame: Up to 5 years post-approval
No study locations are listed for this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Biotronik, Inc.