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The William Harvey Research Institute - Barts and The London

RADIANCE II

The 'Radiance II' Pivotal Study. A study of the ReCor Medical Paradise System in Stage II Hypertension.

Trial objective
The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

Disease area
Hypertension

Status
Open to recruitment

CI/PI
Dr Manish Saxena (PI)

Sponsor
ReCor Medical Inc

Funder
ReCor Medical Inc

Study summary
The ReCor Medical ParadiseĀ® Renal Denervation System (Paradise System) is a catheter-based system that delivers ultrasound energy to thermally ablate and disrupt the renal efferent and afferent sympathetic nerves while sparing the renal arterial wall. The goal of renal nerve ablation is to achieve a reduction in sympathetic over-activity with the resultant effect of reducing systemic arterial blood pressure (BP), and mitigating resultant end-organ damage.

Sample size and duration
225; approximately 5 years

Enquiries  
Dr Manish Saxena: m.saxena@qmul.ac.uk
Armida Balawon: a.balawon@qmul.ac.uk