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

High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02608632
Enrollment
170
Registered
2015-11-20
Start date
2013-02-28
Completion date
2016-02-29
Last updated
2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Renal denervation, Ablation

Brief summary

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

Interventions

DEVICERenal denervation guided by HFS
DEVICERenal denervation as standard procedure

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
number of responders to renal denervation procedure12 month

Secondary

MeasureTime frame
complications rate12 month
cross-over rate12 month

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026