NCT06297291Recruiting
Global Paradise System US Post Approval Study
The Global Paradise® System US Post Approval Study (US GPS)
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 29 Feb 2024
- Start date
- 28 Jun 2024
- Primary completion date
- Dec 2028
- Lead sponsor
- ReCor Medical, Inc.
- Diseases
- High blood pressure
- NCT number
- NCT06297291
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 28 Jun 2024 to the primary completion date, Dec 2028
- 46 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject is pregnant prior to index procedure\^ \^ If a treated subject becomes pregnant after ultrasound RDN procedure, the subject will be followed for outcomes.
- The ultrasound RDN procedure will be performed according to the IFU for the Paradise System and per the site's standard of care for interventional Procedures.
Age
- Subject under the age of 18 years old at the time of consent
Other
- Patients who meet the following will be excluded from participation:
Who the study is looking for
- Signed and dated study informed consent
- Documented history of hypertension
- Documented history of prior or current antihypertensive medication(s)
- Baseline seated office systolic BP at screening ≥ 140 mmHg
- Mean pre-procedure home systolic BP of ≥ 135 mmHg
- Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2
- RADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| Rocky Mountain Regional VAMC Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Ascension Seton Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| St. Luke's Regional Medical Center Coordinator of this site? Confirm its status | Boise | United States | Recruiting |
| The Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Bridgeport Hosptial Coordinator of this site? Confirm its status | Bridgeport | United States | Recruiting |
| NewYork-Presbyterian Brooklyn Methodist Hospital Coordinator of this site? Confirm its status | Brooklyn | United States | Recruiting |
| University at Buffalo Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| University of North Carolina at Chapel Hill School of Medicine Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Prisma Health Richland Hospital Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Metropolitan Heart Vascular Institute Coordinator of this site? Confirm its status | Coon Rapids | United States | Recruiting |
| Dallas VAMC Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Henry Ford St. John Hospital Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Henry Ford Health Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Durham VA Health System Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| AHN Saint Vincent Coordinator of this site? Confirm its status | Erie | United States | Recruiting |
| Inova Fairfax Hospital Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| The Cardiac & Vascular Institute Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| UPMC Harrisburg Coordinator of this site? Confirm its status | Harrisburg | United States | Recruiting |
| Saint Luke's Mid America Heart Institute Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| TCR Institute Coordinator of this site? Confirm its status | Kingwood | United States | Recruiting |
| Tibor Rubin VA Medical Center Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Medical Center of the Rockies Coordinator of this site? Confirm its status | Loveland | United States | Recruiting |
| Wellstar Kennestone Hospital Coordinator of this site? Confirm its status | Marietta | United States | Recruiting |
| Virtua Health Coordinator of this site? Confirm its status | Marlton | United States | Recruiting |
| University of Miami Health System Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Ascension Saint Thomas Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Touro Infirmary Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| NYU Langone Health - Bellevue Hosptial Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Columbia University Medical Center/New York-Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Ascension Sacred Heart Coordinator of this site? Confirm its status | Pensacola | United States | Recruiting |
| Penn Medicine Coordinator of this site? Confirm its status | Phildelphia | United States | Recruiting |
| WakeMed Health and Hospitals Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Sutter Institute for Medical Research Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| UC Davis Medical Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| St. Mark's Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Pacific Heart Institute Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Spartanburg Regional Medical Center Coordinator of this site? Confirm its status | Spartanburg | United States | Recruiting |
| Southern Illinois University, Memorial Medical Center Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Stony Brook Medicine Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
| Tampa Cardiovascular Interventions and Research Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Ascension Via Christi St. Francis Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.