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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 5 years post-approval |
| Measure | Description | Time Frame |
|---|---|---|
| Workflow compliance following MR exposure | Proportion of subjects with appropriate restoration of tachycardia detection and ICD therapy post-MRI. | Up to 5 years post-approval |
| Left ventricular sensing attenuation |
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Inclusion Criteria:
Exclusion Criteria:
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ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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Proportion of subjects who experience left ventricular sensing amplitude attenuation >50% between pre-MRI and 30 days post-MRI.
| Up to 5 years post-approval |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |