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The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal denervation | Experimental | Renal angiography and renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), and maintaining anti-hypertensive medications |
|
| Renal angiography | Sham Comparator | Renal angiography and maintaining anti-hypertensive medications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal denervation | Device | After a renal angiography according to standard procedures, subjects are treated with renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), if without renal anatomic abnormality not detected by Renal CT/CTA. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring | Primary effective outcome measure | from baseline to 3 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in office systolic blood pressure | Secondary effective outcome measure | from baseline to 3 months post-procedure |
| Classes of anti-hypertensive medicine taken by participants | Secondary effective outcome measure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum creatinine | Safety outcome assessment | from baseline to 3 months post-procedure and 6 months post-procedure |
| Incidence of renal stenosis | Safety outcome assessment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayi Wang | Contact | +86-18511291205 | jiayi.wang@synapticmed.com.cn | |
| Qing Liu | Contact | +86-18701241121 | qing.liu@synapticmed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yong Huo | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Renal angiography | Diagnostic Test | A renal angiography according to standard procedure. |
|
| 6 months post-procedure |
| Incidence of achieving target office systolic blood pressure (office SBP<140mmHg) | Secondary effective outcome measure | from 3 months post-procedure to 6 months post-procedure |
| 6 months post-procedure |
| Other acute and chronic safety evaluating by the incidence of major adverse event | Safety outcome assessment | 6 months post-procedure |