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The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleuth Implantable ECG Monitoring System | Device | The study device provides monitoring only. It cannot provide intervention or treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostically viable ECG signals | daily |
| Measure | Description | Time Frame |
|---|---|---|
| rate of device-related adverse events | 1, 6, and 12 months |
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Inclusion Criteria:
Age > = 18 years at time of enrollment
Either of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wim Stegink | Transoma Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Paitilla | Panama City | Panama |
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| Label | URL |
|---|---|
| Sponsor website | View source |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D013575 | Syncope |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |