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RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.
Full description
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. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication (SOLO) or despite the presence of a stabilized, single pill, triple, fixed dose antihypertensive medication regimen (TRIO).
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Inclusion and exclusion criteria
TRIO and SOLO Inclusion Criteria:
Solo Exclusion Criteria:
Renal artery anatomy on either side, ineligible for treatment including:
Evidence of active infection within 7 days of procedure
Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%)
Documented history of chronic active inflammatory bowel disorders such as Chrohn's disease or ulcerative colitis
eGFR of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
Brachial circumference ≥ 42 cm
Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident)
Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV)
Documented confirmed episode(s) of stable or unstable angina
Documented repeat (>1) hospitalization for hypertensive crisis within the prior 12 months
Prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health
Documented history of persistent or permanent atrial tachyarrhythmia
Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
Primary pulmonary hypertension
Documented contraindication or allergy to contrast medium not amenable to treatment
Limited life expectancy of < 1 year at the discretion of the Investigator
Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders (e.g. night shift workers)
Pregnant, nursing or planning to become pregnant (negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential) Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)
TRIO Exclusion Criteria
Renal artery anatomy on either side, ineligible for treatment including:
Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
Evidence of active infection within 7 days of procedure
Secondary hypertension not including sleep apnea (documented through clinical work up within the 12 months prior to consent- see protocol body for details)
Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%)
Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis
eGFR of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
Brachial circumference ≥ 42 cm
Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 3 months prior to consent
Any history of severe cardiovascular event (e.g. myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 3 months prior to consent
Documented repeat (>1) hospitalization for hypertensive crisis within the prior 3 months
Documented confirmed episode(s) of unstable angina within 3 months prior to consent
Documented intolerance or contraindication for any of the antihypertensive drugs prescribed as a requirement of the study protocol
Prescribed to any standard anti-hypertensive CV medication (other than beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health
Documented history of persistent or permanent atrial tachyarrhythmia
Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
Primary pulmonary hypertension
Documented contraindication or allergy to contrast medium not amenable to treatment
Limited life expectancy of < 1 year at the discretion of the Investigator
Night shift workers
Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders
Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential)
Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)
Primary purpose
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Interventional model
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282 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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