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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Renal denervation guided by HFS
Renal denervation as standard procedure
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Renal denervation, Ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Federal Center of Cardiovascular surgery
  • Regional Hospital
  • Federal Center of Prophylactic Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 (RDN guided by HFS)

Group 2 (RDN as standard procedure)

Arm 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.

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

Outcomes

Primary Outcome Measures

number of responders to renal denervation procedure

Secondary Outcome Measures

complications rate
cross-over rate

Full Information

First Posted
November 17, 2015
Last Updated
November 19, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02608632
Brief Title
HFS-guided Renal Ablation for Improving Outcome of Renal Denervation Procedure
Official Title
High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Renal denervation, Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (RDN guided by HFS)
Arm Type
Experimental
Arm 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.
Arm Title
Group 2 (RDN as standard procedure)
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Renal denervation guided by HFS
Intervention Type
Device
Intervention Name(s)
Renal denervation as standard procedure
Primary Outcome Measure Information:
Title
number of responders to renal denervation procedure
Time Frame
12 month
Secondary Outcome Measure Information:
Title
complications rate
Time Frame
12 month
Title
cross-over rate
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Federal Center of Cardiovascular surgery
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Regional Hospital
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Federal Center of Prophylactic Medicine
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

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

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