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This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a patch monitoring system, with the Holter monitoring system. Holters represent the current standard for continuous recording of the ECG over extended periods.
The purpose of this research is to simplify the system of recording ECGs. Carnation Ambulatory Monitoring (CAM) System is a small patch system that can be worn during most activities include showering. Each patient will be his or her own control, and will wear the CAM and Holter systems simultaneously for 24 hours. Both systems will then be sent out for analysis.
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| Measure | Description | Time Frame |
|---|---|---|
| ECG signal quality | ECG signal quality = scoring the ability of each system to record electrical activity from the atrium (P-waves). The Physician Event Committee will independently score the P-waves from all recordings, using the following scale: Excellent, Good, Fair, Poor, Non-existent. Diagnostic yield will also be assessed. | 24 hours of patient use, plus shipping and analysis time ~ 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Device comfort | Secondary outcome measures will include Human Factors performance of the 2 systems, which will be scored and compared in the following areas and duration of patch adherence: skin irritation, comfort, contact and stability. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Cardiac patients at Auckland City Hospital, Auckland, New Zealand
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| Name | Affiliation | Role |
|---|---|---|
| Jon Hunt, PhD | Bardy Diagnostics, Inc. (sponsor) | Study Director |
| Warren Smith, MBChB | Auckland City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland City Hospital | Auckland | 1142 | New Zealand |
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| ID | Term |
|---|---|
| D013575 | Syncope |
| D001281 | Atrial Fibrillation |
| D013617 | Tachycardia, Supraventricular |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |