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ClinicalTrials.gov ID

NCT02029885

Lead Sponsor

Kona Medical Inc.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

132Estimated

Last Update Posted

Jan 8, 2016Estimated

Start Date

Aug 2014

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2018Estimated

Official Title

Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

Brief Summary

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.

Detailed 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.

• Hypertension

• Investigational Therapy (Surround Sound)
• Sham Control

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Subject is at least 18 years of age and no more than 90 years of age

2. Average SBP ≥ 160 mmHg

3. 24 hour average ABPM daytime SBP ≥ 135 mmHg.

4. No medication changes for a minimum of 1 months prior to screening.

5. 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:

   1. Highest labeled dose according to medication's labeling;
   2. Highest usual dose per clinical guidelines JNC-7;
   3. Highest tolerated dose; and/or
   4. Highest appropriate dose for the subject per the PI's clinical judgment.

6. Subject has two functioning kidneys.

7. Subject has an eGFR value of ≥ 30 ml/min/1.73 m² (MDRD formula).

Exclusion Criteria:

1. Subject has any secondary cause of hypertension
2. Subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and Doppler analysis on ultrasound
3. Subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
4. Subject has a history of intra-abdominal surgery within the past six months
5. 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.
6. Stenotic valvular heart disease for which BP reduction would be hazardous as determined by referring physician.
7. MI, unstable angina, or CVA in the prior 6 months.
8. Known severe primary pulmonary HTN
9. Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
10. Subject has hemodynamically significant valvular heart disease.
11. Subject has BMI over 40 km/m^2
12. Subject has a target treatment depth over 13 cm.
13. Subject has anatomy that precludes treatment with the Kona Medical Surround Sound System.
14. Subject is pregnant, nursing, or intends to become pregnant during the trial period.
15. Subject is currently enrolled in other potentially confounding research.
16. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
17. Subject is unable, or unwilling, to comply with the protocol-required follow-up schedule

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Kona Medical Inc.INDUSTRY

tatjana.schewior@uk-koeln.de+49 (221) 478 88273