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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON |
|
| 2 | No Intervention | No Care Alerts available, standard treatment of the patient |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device triggered remote telephone contact because of Care Alert | Behavioral | Care Alerts on, physician will be notified in case of an Care Alert. Depending on the outcome of the telephone contact drug adjustment and / or further interventions can be prescribed |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first hospitalization due to worsened heart failure | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making | 15 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Zabel, MD | University Hospital of Goettingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Goettingen | Göttingen | 37099 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23073567 | Background | Zabel M, Vollmann D, Luthje L, Seegers J, Sohns C, Zenker D, Hasenfuss G. Randomized Clinical evaluatiON of wireless fluid monitoriNg and rEmote ICD managemenT using OptiVol alert-based predefined management to reduce cardiac decompensation and health care utilization: the CONNECT-OptiVol study. Contemp Clin Trials. 2013 Jan;34(1):109-16. doi: 10.1016/j.cct.2012.10.001. Epub 2012 Oct 13. | |
| 25983310 |
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|
| Result |
| Luthje L, Vollmann D, Seegers J, Sohns C, Hasenfuss G, Zabel M. A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices. Europace. 2015 Aug;17(8):1276-81. doi: 10.1093/europace/euv039. Epub 2015 May 17. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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