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The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOMONITOR III | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOMONITOR III | Device | Patients with ICM indication receive a third-generation implantable cardiac monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | (procedure / device related) | 1 month |
| R-wave amplitude | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion procedure of the BIOMONITOR III by using the incision and insertion tools | Assessment of insertion procedure by using a questionaire about handling and time record. | At the day of insertion of the BIOMONITOR III |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier van den Brink, Dr. | The Alfred Hospital, Melbourne, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HeartCare Partners - Wesley Testing | Auchenflower | Queensland | 4066 | Australia | ||
| Bundaberg Cardiology |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013575 | Syncope |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Bundaberg |
| Queensland |
| 4670 |
| Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| HeartCare Victoria - Doncaster | Balwyn | Victoria | 3103 | Australia |
| Mount Hospital | Perth | Western Australia | 6000 | Australia |
| The Canberra Hospital | Canberra | 2605 | Australia |
| The Alfred Hospital | Melbourne | 3004 | Australia |
| 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 |
| D000075224 | Cardiac Conduction System Disease |