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The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal denervation | Experimental | Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-based Renal Denervation | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Major adverse events | All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in office blood pressure measurement | 30 days, 3 months, 6 months, 9 months, 12 months | |
| Change from baseline in ambulatory 24-hour blood pressure measurement | 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David A. Smith | Contact | dsmith@sounditv.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital | Recruiting | Prague | Czechia |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Change from baseline in renal artery dimensions | Change in renal artery dimensions as measured by renal angiography, CT, or MRI | 30 days |
| Change from baseline in creatinine | 6 months |
| Adverse events and device complications | 12 months |