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To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (RDN guided by HFS) | Experimental | Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. After that high-frequency stimulation (HFS) was used before the initial and after each radiofrequency (RF) delivery within the renal artery. RDN was considered to have been achieved when the sudden increase of blood pressure (> 15 mm Hg from invasive arterial monitoring) was eliminated in response to HFS. RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. |
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| Group 2 (RDN as standard procedure) | Active Comparator | Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. High-frequency stimulation (HFS) was performed before and after RDN to just to verify the response of BP |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal denervation guided by HFS | Device |
| ||
| Renal denervation as standard procedure |
| Measure | Description | Time Frame |
|---|---|---|
| number of responders to renal denervation procedure | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| complications rate | 12 month | |
| cross-over rate | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Center of Cardiovascular surgery | Krasnoyarsk | Russia | ||||
| Regional Hospital |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Device |
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| Krasnoyarsk |
| Russia |
| Federal Center of Prophylactic Medicine | Moscow | Russia |