Global Paradise System US Post Approval Study

Recruiting now

Conditions studied: Hypertension, Cardiovascular Diseases, Vascular Diseases

In brief

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.

Key facts

Study ID

NCT06297291

Run by

ReCor Medical, Inc.

People needed

1000

Starts

2024-06-28

Expected to finish

2031-07-01

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Sutter Institute for Medical Research — Sacramento, California, United States (enrolling)
• UC Davis Medical Center — Sacramento, California, United States (enrolling)
• Pacific Heart Institute — Santa Monica, California, United States (enrolling)
• Rocky Mountain Regional VAMC — Aurora, Colorado, United States (enrolling)
• Bridgeport Hosptial — Bridgeport, Connecticut, United States (enrolling)
• The Cardiac & Vascular Institute — Gainesville, Florida, United States (enrolling)
• University of Miami Health System — Miami, Florida, United States (enrolling)
• Ascension Sacred Heart — Pensacola, Florida, United States (enrolling)
• Tampa Cardiovascular Interventions and Research — Tampa, Florida, United States (enrolling)
• Wellstar Kennestone Hospital — Marietta, Georgia, United States (enrolling)
• Southern Illinois University, Memorial Medical Center — Springfield, Illinois, United States (enrolling)
• Ascension via Christi St. Francis — Wichita, Kansas, United States (enrolling)
• Touro Infirmary — New Orleans, Louisiana, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• The Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• Metropolitan Heart & Vascular Institute — Coon Rapids, Minnesota, United States (enrolling)
• Saint Luke's Mid America Heart Institute — Kansas City, Missouri, United States (enrolling)
• Virtua Health — Marlton, New Jersey, United States (enrolling)
• Albany Medical Center — Albany, New York, United States (enrolling)
• NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States (enrolling)
• University at Buffalo — Buffalo, New York, United States (enrolling)
• NYU Langone Health - Bellevue Hosptial — New York, New York, United States (enrolling)
• Columbia University Medical Center/New York Presbyterian Hospital — New York, New York, United States (enrolling)
• Stony Brook Medicine — Stony Brook, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.