Wave VI Feasibility Study
Research type
Research Study
Full title
Wave VI Feasibility Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension
IRAS ID
190696
Contact name
Mel Lobo
Contact email
Sponsor organisation
Kona Medical Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 29 days
Research summary
Hypertension (high blood pressure) is a major health problem affecting approximately 1.2 billion people and is associated with an increased risk of stroke, coronary artery disease and heart failure. Renal denervation provides a potential option for these patients to help reduce their lifetime risk of cardiovascular and other hypertensive related adverse outcomes.
The purpose of this clinical study is to evaluate the safety of Surround Sound System of the Kona Medical renal denervation system and to determine if it is effective for patients with less severe levels of hypertension who are not treated with antihypertensive medications due to a number of circumstances, such as intolerance, access and non-compliance. The Surround Sound System delivers treatment completely non-invasively. The previous three trials of phase II study of the Kona Surround Sound System and the extensive preclinical work have established the safety and early efficacy of this treatment supporting its further study in this trial.
The Kona surround sound system study is a, multicentre, prospective, double-blind, randomised, sham controlled feasibility of the safety of renal denervation in patients with stage I and II hypertension who have an average office systolic blood pressure between 150 and 180 mmHg and have not been on any antihypertensive medications for at least six months. Bilateral renal denervation will be performed non-invasively using the Kona Medical Surround Sound System by delivering focused ultrasound therapy to ablate the nerves surrounding the renal artery utilizing real time ultrasound for targeting and tracking.
In this study sixty participants will be randomized in a 2:1 fashion and treated. Subject participation would last 52 weeks and involves 9 visits. Subjects from the sham control group will be offered the option to cross over and undergo renal denervation with the Kona Surround Sound system after all subjects have completed the 6 months follow up time point.REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0143
Date of REC Opinion
18 Feb 2016
REC opinion
Unfavourable Opinion