NCT06297291 · ReCor Medical, Inc.
Global Paradise System US Post Approval Study
(US GPS)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Signed and dated study informed consent
- Documented history of hypertension
- Documented history of prior or current antihypertensive medication(s)
- Mean 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.
Exclusion criteria
- Patients who meet the following will be excluded from participation:
- Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter
- Patient under the age of 18 years old at the time of consent
- Patient is pregnant
- Patients with transplanted kidney
- Presence of abnormal kidney (or secreting adrenal) tumors To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment:
- Renal arteries with diameter \< 3mm and \> 8mm
- Renal artery with fibromuscular dysplasia (FMD)
- Stented renal artery
- Renal artery aneurysm
- Renal artery diameter stenosis \>30%
- Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
Where
- Sacramento, California
- Santa Monica, California
- Aurora, Colorado
- Bridgeport, Connecticut
- Gainesville, Florida
- Miami, Florida
- Pensacola, Florida
- Tampa, Florida
- Marietta, Georgia
- Springfield, Illinois
- Wichita, Kansas
- New Orleans, Louisiana
And 24 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 7, 2026 · Source of record for eligibility and locations