Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioMonitor 2 | Device | Implantation of BioMonitor 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2 | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| R-Wave amplitude ≥ 0.3 mV | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The patient collective consists mainly of patients with indications of an insertable cardiac monitor or who are planned for loop recorded guided AF-therapy management. The investigator will select patients who are appropriate for particiation from his general patient population.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher Piorkowski, MD | Heart Center Dresden, Germany | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001281 | Atrial Fibrillation |
| D013575 | Syncope |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
| D010335 | Pathologic Processes |
| 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 |