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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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The goal of this clinical trial is to learn weather the baroloop system is safe and works to treat hypertension in adults that do not respond sufficiently to medication. The main questions it aims to answer are:
Participants will be implanted with the baroloop device. Afterwards they will visit the clinic after 14 days, 3 months, 6 months, 12 months, 18 months, and 24 months for adjustment of the device settings and/or other study related assessments. Participants will also be asked to answer questions regarding their quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Implantation of the baroloop device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| baroloop system | Device | Participants will have the baroloop device implanted for selective stimulation of the vagus nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the baroloop device | Composite Major Adverse Event (MAE) Rate including all-causes of death and all device or procedure-related serious adverse event | 6 months after initial stimulation |
| Performance | Change in mean 24-hour Systolic Ambulatory Blood Pressure (ABP) by ambulatory blood pressure monitoring | 6 months after initial stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Scientific Affairs | Contact | +49 761 1543390 | study@neuroloop.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clemenshospital Münster | Recruiting | Münster | North Rhine-Westphalia | 48153 | Germany |
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| ID | Term |
|---|---|
| C563514 | Hypertension Resistant to Conventional Therapy |
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| Marienhaus Klinikum Mainz | Recruiting | Mainz | Rhineland-Westphalia | 55131 | Germany |
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| Städtisches Klinikum Dresden | Recruiting | Dresden | Saxony | 01067 | Germany |
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| UMC Utrecht | Recruiting | Utrecht | Utrecht | 3584 CX | Netherlands |
|