Radiance HTN study of ReCor Paradise System in Clinical Hypertension.
Trial objectiveThe objective of the RADIANCE-HTN study is to demonstrate the efficacy and verify the safety of the Paradise System in two distinct populations of hypertensive subjects. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication or despite the presence of a stabilized, single pill, triple, fixed-dose antihypertensive medication regimen.
StatusClosed to recruitment
CI/PIManish Saxena (PI)
SponsorReCor Medical Inc
FunderReCor Medical Inc
Study summaryRADIANCE-HTN is a randomized, double-blind, sham-controlled, 2-cohort study designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.
Two study cohorts will be evaluated. Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort while subjects with treatment-resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort.
The ReCor Medical Paradise® 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 duration128 on each cohort; approximately 60 months
Enquiries Dr Manish Saxena: firstname.lastname@example.orgArmida Balawon: email@example.com