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The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea.
DENEX system developed by Handok Kalos Medical Inc. is a renal nerve blocking system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal denervation therapy group | Experimental | The subject treated by renal denervation by using DENEX system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal denervation | Device | DENEX catheter is a device to treat resistant hypertension which delivers high-frequency energy through the three electrodes connected to the catheter in order to cauterize sympathetic nerve bundle. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all adverse events | rate of major adverse events for 1 month after the treatment | From baseline to 1 month post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory SBP change at 3,6,12,24 months | Change in systolic blood pressure as measured by 24-hour ABPM at 3, 6, 12, 24 months post denervation | From baseline to 3, 6, 12, 24 months post-procedure |
| Office SBP change at 1, 3, 6, 12, 18, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yangsu Jang | Division of Cardiology, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Pusan | South Korea | ||||
| Severance Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33377328 | Derived | Kim CJ, Chang K, Kim BK, Park CG, Jang Y. An Open-label, Single-arm, Multicenter Feasibility Study Evaluating the Safety of Catheter-based Renal Denervation with DENEX in Patients with Uncontrolled Hypertension on Standard Medical Therapy. Korean Circ J. 2021 Jan;51(1):43-55. doi: 10.4070/kcj.2020.0391. |
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Change in office systolic blood pressure at 1, 3, 6, 12, 18, 24 months post denervation
| From baseline to 1, 3, 6, 12, 18, 24 months post-procedure |
| Percentage of decreased office SBP >10, 15, 20 mmHg | Percentage of subjects decreased office systolic blood pressure > 10 mmHg, 15 mmHg, 20 mmHg at 1, 3, 6, 12, 18, 24 months post denervation | From baseline to 1, 3, 6, 12, 18, 24 months post-procedure |
| Seoul |
| 03722 |
| South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Seoul St.Mary's Hospital | Seoul | South Korea |
| Uijeongbu St. Mary's Hospital | Uijeongbu-si | South Korea |