A Phase 2 interventional study of Renal denervation guided by HFS and Renal denervation as standard procedure in Hypertension, sponsored by Meshalkin Research Institute of Pathology of Circulation. Status unknown at 3 sites in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-11-20.
Sponsored by Meshalkin Research Institute of Pathology of Circulation · Phase 2, Interventional, and Treatment
To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 170 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 114 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
Device: Renal denervation guided by HFS
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
Device: Renal denervation as standard procedure
number of responders to renal denervation procedure
Time frame: 12 month
complications rate
Time frame: 12 month
cross-over rate
Time frame: 12 month
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Meshalkin Research Institute of Pathology of Circulation