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

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ClinicalTrials.gov Identifier: NCT02608632
Recruitment Status : Unknown
Verified November 2015 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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

Condition or disease Intervention/treatment Phase
Hypertension Device: Renal denervation guided by HFS Device: Renal denervation as standard procedure Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure
Study Start Date : February 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Device: Renal denervation guided by HFS
Active Comparator: 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

Device: Renal denervation as standard procedure



Primary Outcome Measures :
  1. number of responders to renal denervation procedure [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. complications rate [ Time Frame: 12 month ]
  2. cross-over rate [ Time Frame: 12 month ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608632


Locations
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Russian Federation
Federal Center of Cardiovascular surgery
Krasnoyarsk, Russian Federation
Regional Hospital
Krasnoyarsk, Russian Federation
Federal Center of Prophylactic Medicine
Moscow, Russian Federation
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02608632    
Other Study ID Numbers: 7452RDNHFS
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Renal denervation
Ablation
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases