Radiance HTN study of ReCor Paradise System in Clinical Hypertension
Research type
Research Study
Full title
The “RADIANCE HTN” Study. A study of the ReCor Paradise System in Clinical Hypertension.
IRAS ID
182955
Contact name
Helen Reeve-Stoffer
Contact email
Sponsor organisation
ReCor Medical Inc c/o Clinical Venture Services Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 10 months, 17 days
Research summary
The RADIANCE-HTN study aims to demonstrate the ability of the Paradise System to effectively reduce systolic daytime Ambulatory Blood Pressure in subjects experiencing hypertension (high BP). The study is also designed to document the safety profile of the Paradise System in all treated subjects. \nThe ReCor Paradise® Renal Denervation System (Paradise System) is a catheter-based (a thin, flexible plastic tube with a small plastic balloon on the end) system that delivers ultrasound energy to heat, treat and thus disable the renal sympathetic nerves located in the adventitia, while sparing the renal arterial wall from damage through the use of a water cooled balloon. The goal of renal nerve ablation is to achieve a reduction in the over-activity of sympathetic nerves with the resultant effect of reducing systemic arterial blood pressure (BP), and mitigating resultant end organ damage.\nThe study will run in approximately 40 hospitals in the UK, Europe and USA and will enrol and randomize up to 292 patients with either essential hypertension following drug wash-out (the “Solo“ cohort, n=146) or treatment-resistant hypertension on standardized medication (the Trio cohort, n=146). Eligible subjects will be stratified into one of the two cohorts and randomized to treatment or placebo (sham procedure). All subjects will undergo a hospital procedure (a diagnostic renal angiogram) but will be blinded as to whether they have received the treatment. Clinical staff conducting follow-ups will also be blinded.\nThe subjects will attend clinic for screening and eligibility checks prior to the treatment or control procedure, and then post hospital discharge the subject will attend clinic for up to 9 follow up visits over a minimum duration of three years. During the study period, subjects will have their blood pressure monitored, both at the clinic and at home. Blood pressure medications will also be carefully controlled and monitored.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/0124
Date of REC Opinion
26 Feb 2016
REC opinion
Further Information Favourable Opinion