Wave IV study
Research type
Research Study
Full title
Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects with Uncontrolled Hypertension
IRAS ID
147250
Contact name
Melvin Lobo
Contact email
Sponsor organisation
Kona Medical Inc. (KMI)
Clinicaltrials.gov Identifier
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. Only about half of all patients treated are able to have their blood pressure controlled to target levels with medications (the main form of treatment), indicating a need for new ways to treat hypertension.
The purpose of this clinical study is to evaluate the safety of the Kona Medical renal denervation system (Surround Sound System) and to determine if it is effective in the treatment of hypertension. In this study, the system will use an external imaging system to locate and treat the renal nerves.
Wave IV is an international, sham controlled, double blind study of subjects with uncontrolled hypertension consisting of two arms, sham and therapy. For eligible subjects who have failed other renal denervation technologies, treatment will be offered but these subjects will not be randomized or blinded to therapy and will not count toward the total study population. The study’s goal is to assess the safety and effectiveness of renal denervation. 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.
Approximately 320 subjects will be screening to allow for 132 subjects to be randomized in the two arm sham controlled randomized portion of the study and up to 28 subjects to be treated in the non-randomized arm of the study. The study will be conducted at up to 12 actively enrolling clinical sites. Subject participation would last 24 months and involves 11 visits.
REC name
West of Scotland REC 1
REC reference
14/WS/1014
Date of REC Opinion
20 Aug 2014
REC opinion
Further Information Favourable Opinion