HFS-guided Renal Ablation for Improving Outcome of Renal Denervation Procedure

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Hypertension

Treatments: Device: Renal denervation guided by HFS; Device: Renal denervation as standard procedure

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02608632

7452RDNHFS

Details and patient eligibility

About

To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Office-based systolic blood pressure of ≥140/90 mm Hg and <160/100 mm Hg (moderate resistant hypertension) or ≥160/100 mm Hg (severe resistant hypertension), despite treatment with 3 antihypertensive drugs (including a diuretic).
• A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula.

Exclusion criteria

• Secondary causes of hypertension
• Severe renal artery stenosis or dual renal arteries
• Congestive heart failure
• Left ventricular ejection fraction <35%
• Previous renal artery stenting or angioplasty
• Type 1 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Group 1 (RDN guided by HFS)

Experimental group

Description:

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.

Treatment:

Device: Renal denervation guided by HFS

Group 2 (RDN as standard procedure)

Active Comparator group

Description:

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

Treatment:

Device: Renal denervation as standard procedure