Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Previously or currently prescribed antihypertensive therapy
  • Average office BP ≥ 140/90 mmHg <180/120 mmHg while stable for at least 4 weeks on 0-2 classes of antihypertensive medication
  • Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in period

Exclusion Criteria

  • Lacks appropriate renal artery anatomy for treatment
  • Known, uncorrected causes of secondary hypertension other than sleep apnea
  • Type I diabetes mellitus or uncontrolled Type II diabetes
  • eGFR of <40
  • Brachial circumference ≥ 42 cm
  • Any history of cerebrovascular event or severe cardiovascular event, or history of stable or unstable angina within 12 months prior to consent
  • Repeat (>1) hospitalization for hypertensive crisis within 12 months prior to screening period, or any hospitalization for hypertensive crisis within 3 months prior to screening period
  • Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
  • Primary pulmonary hypertension
  • Night shift workers
  • Pregnant, nursing or planning to become pregnant

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Renal Denervation
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
  • Device: Paradise Renal Denervation System
    Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
    Other names:
    • Renal Angiogram
    • Renal Denervation
Sham Comparator
Sham Control
Renal Angiogram
  • Procedure: Renal Angiogram
    Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

Recruiting Locations

MedStar Washington
Washington, District of Columbia 20010
Contact:
Suman Singh, MD
suman.singh@medstar.net

More Details

Status
Recruiting
Sponsor
ReCor Medical, Inc.

Study Contact

Helen Reeve-Stoffer, PhD
+44 7947 748006
hreeve-stoffer@recormedical.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.