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The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. The study will be conducted to support regulatory approvals outside of Europe. This BioMonitor Master study is designed to investigate the clinical efficacy and safety of the BioMonitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantable cardiac monitor diagnostics | Patients has standard indication for implantable cardiac monitor diagnostic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioMonitor | Device | Implantable cardiac monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| SADE free-rate | SADE free-rate > 90% at 3 month follow-up | at 3 month follow-up |
| Rate of appropriate QRS detection | Rate of appropriate QRS detection > 90% (based on comparison with Holter ECG recording) | at 6 week follow-up |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Positive Predictive of episode detection | Sensitivity and Positive Predictive Value of each automatically detected cardiac arrhythmia that was stored as subcutaneous electrocardiogram by the BioMonitor (6 week, 3 and 12 month follow-up data) | 1 year |
| Adverse events |
Inclusion Criteria:
Exclusion Criteria:
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Patients with standard ICM indication who are referred to the hospital
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| Name | Affiliation | Role |
|---|---|---|
| Dietmar Baensch, Professor | University of Rostock, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rostock | Rostock | 18057 | Germany |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013575 | Syncope |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |