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The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
NCT03614260 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DEVICE Paradise Renal Denervation System
- PROCEDURE Renal Angiogram
Study Locations (20)
Connecticut
- Bridgeport Hospital — Bridgeport
- Stamford Hospital — Stamford
Illinois
- Northwestern University — Chicago
- Southern Illinois University — Springfield
New Jersey
- Deborah Heart & Lung Center — Browns Mills
- Hackensack University — Hackensack
New York
- Columbia University Medical Center/NYPH — New York
- Northwell Health Inc. — New York
Alabama
- Cardiology PC — Birmingham
California
- Cedars Sinai Medical Center — Los Angeles
District of Columbia
- MedStar Washington — Washington D.C.
Florida
- The Cardiac and Vascular Institute — Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2018-12-14 |
| Est. Completion | 2027-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03614260
The ClinicalTrials.gov registry entry for NCT03614260 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ReCor Medical, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Hypertension appearing as the primary indexed condition, and to 2 interventions — of which Paradise Renal Denervation System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03614260 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Connecticut, Illinois, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03614260 about?
NCT03614260 is a clinical study titled "The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension". 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.
What is the current status of trial NCT03614260?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 225 participants. The study started on 2018-12-14. Estimated completion is 2027-07.
What conditions does trial NCT03614260 study?
This clinical trial studies the following conditions: Hypertension, Cardiovascular Diseases, Vascular Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03614260?
The interventions under investigation include: Paradise Renal Denervation System (DEVICE), Renal Angiogram (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03614260?
This trial is sponsored by ReCor Medical, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03614260 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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