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

NCT ID: NCT02608632

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-02-29

Brief Summary

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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

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1 (RDN 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. 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.

Group Type EXPERIMENTAL

Renal denervation guided by HFS

Intervention Type DEVICE

Group 2 (RDN as standard procedure)

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

Group Type ACTIVE_COMPARATOR

Renal denervation as standard procedure

Intervention Type DEVICE

Interventions

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Renal denervation guided by HFS

Intervention Type DEVICE

Renal denervation as standard procedure

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Federal Center of Cardiovascular surgery

Krasnoyarsk, , Russia

Site Status

Regional Hospital

Krasnoyarsk, , Russia

Site Status

Federal Center of Prophylactic Medicine

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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7452RDNHFS

Identifier Type: -

Identifier Source: org_study_id