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To evaluate the safety and performance of the ConfidenHT System
To evaluate the safety and performance of the ConfidenHT System for diagnostic mapping of renal nerves; functional distribution of renal nerves and the effect of renal nerve stimulation on the blood pressure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ConfidenHT system | Experimental | ConfidenHT system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ConfidenHT system | Device | ConfidenHT Medical system |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of serious adverse events (system and/or procedure related events) | The incidence of serious adverse events (system and/or procedure related events) | 3 months |
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Inclusion Criteria:
Signed written informed consent.
Age >18 years and <75.
Either:
Main renal artery with diameter ≥ 4.0mm.
Glomerular Filtration Rate (GFR) >45 mL/min
A patient who is mentally competent with the ability to understand and comply with the requirements of the study.
The patient agrees to attend all follow-up evaluations and is willing to complete required exams and tests.
Female patients with childbearing potential must agree:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kostas Tsioufis, MD | Hippocratio Hospital, Athens, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hippocratio Hospital | Athens | Greece | ||||
| EMC |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Rotterdam |
| Netherlands |
| UMC | Utrecht | Netherlands |