Verified January 2016 by Kona Medical Inc..
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.
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.
Safety will be assessed by incidence of Major Adverse Events (MAE), defined as a composite of the following events at 6-weeks follow-up.
Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications as assessed by toxicological and other medical analyses and testing.
Change in Office Systolic Blood Pressure (OBP) as measured from screening visit one to the 6 month post randomization follow-up visit.
Hospitalization for hypertensive crisis not confirmed non-adherence with medications.
Reduction in systolic and diastolic blood pressure as compared between groups at time points through the 6 month follow-up period for interval differences of 10,15 and 20 mmHg.
Incidence of achieving target OBP (< 140 mmHg) through the 6 month follow-up period.
Incidence of reductions in the number of anti-hypertensive medications and reductions in the doses of anti-hypertensive medications.
Changes in OBP from screening to the 12, 18, and 24 month follow-up periods.
Changes in HR (as measured by OBP and ABPM) through the 6 month follow-up period.
24 hour average ABPM daytime SBP ≥ 135 mmHg.
No medication changes for a minimum of 1 months prior to screening.
Highest appropriate dose for the subject per the PI's clinical judgment.
Subject has two functioning kidneys.
Subject has an eGFR value of ≥ 30 ml/min/1.73 m² (MDRD formula).
Subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment.
Stenotic valvular heart disease for which BP reduction would be hazardous as determined by referring physician.
MI, unstable angina, or CVA in the prior 6 months.
Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
Subject has hemodynamically significant valvular heart disease.
Subject has a target treatment depth over 13 cm.
Subject has anatomy that precludes treatment with the Kona Medical Surround Sound System.
Subject is pregnant, nursing, or intends to become pregnant during the trial period.
Subject is currently enrolled in other potentially confounding research.
Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
Saxena M, Shour T, Shah M, Wolff CB, Julu POO, Kapil V, Collier DJ, Ng FL, Gupta A, Balawon A, Pheby J, Zak A, Rull G, O'Brien B, Schmieder RE, Lobo MD. Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success. J Am Heart Assoc. 2018 Jun 12;7(12). pii: e009151. doi: 10.1161/JAHA.118.009151.
Responsible Party: Kona Medical Inc.