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To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.
Full description
This study is a sham controlled, double blind study of subjects with uncontrolled hypertension consisting of two arms, sham and therapy. Bilateral renal denervation will be performed non-invasively using the Kona Medical Surround Sound System which delivers focused ultrasound therapy to ablate the nerves surrounding the renal artery utilizing real time ultrasound for targeting and tracking.
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Inclusion criteria
Subject is at least 18 years of age and no more than 90 years of age
Average SBP ≥ 160 mmHg
24 hour average ABPM daytime SBP ≥ 135 mmHg.
No medication changes for a minimum of 1 months prior to screening.
At minimum, subject must be on at least three antihypertensive medications, with one being a diuretic, and each must meet one or more of the following full dose criteria:
Subject has two functioning kidneys.
Subject has an eGFR value of ≥ 30 ml/min/1.73 m² (MDRD formula).
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132 participants in 2 patient groups
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Central trial contact
Omar Dawood
Data sourced from clinicaltrials.gov
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