The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension (NCT03614260)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (12 items).
Location: Cardiology PC — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (47 Sites)
- Cardiology PC — Birmingham, Alabama
- Cedars Sinai Medical Center — Los Angeles, California
- Bridgeport Hospital — Bridgeport, Connecticut
- Stamford Hospital — Stamford, Connecticut
- MedStar Washington — Washington D.C., District of Columbia
- The Cardiac and Vascular Institute — Gainesville, Florida
- Emory University Hospital Midtown — Atlanta, Georgia
- Northwestern University — Chicago, Illinois
- Southern Illinois University — Springfield, Illinois
- Ochsner Heart and Vascular Institute — New Orleans, Louisiana
- The Brigham and Women's Hospital — Boston, Massachusetts
- Munson Medical Center — Traverse City, Michigan
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota
- Saint Luke's Health System — Kansas City, Missouri
- Renown Regional Medical Center — Reno, Nevada
- Deborah Heart & Lung Center — Browns Mills, New Jersey
- Hackensack University — Hackensack, New Jersey
- Columbia University Medical Center/NYPH — New York, New York
- Northwell Health Inc. — New York, New York
- The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- University of Pennsylvania Health System — Philadelphia, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- The University of Tennessee Health Science Center — Memphis, Tennessee
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.