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NCT03614260 · ClinicalTrials.gov registry record · NA
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
A NA study of Hypertension and Cardiovascular Diseases, sponsored by ReCor Medical.
- Active
- Registry status
- NA
- Development phase
- 225
- Enrollment target
- 20
- Study locations
NCT03614260 is a NA study of Hypertension and Cardiovascular Diseases that is active but no longer recruiting, run by ReCor Medical. The registered enrollment target is 225 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT03614260, a NA study of Hypertension and Cardiovascular Diseases, is active but no longer recruiting, sponsored by ReCor Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 225 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (94% lower). The listed sponsor is ReCor Medical, which has 5 total studies on file at ClinicalTrials.gov.
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.
NCT03614260 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Connecticut, Illinois, New Jersey.
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.
What interventions are being tested in trial NCT03614260?
The interventions under investigation include: Paradise Renal Denervation System (DEVICE), Renal Angiogram (PROCEDURE).
Who is sponsoring clinical trial NCT03614260?
This trial is sponsored by ReCor Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
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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