Global Paradise System US Post Approval Study
Recruiting · NCT06297291 · Observational (researchers observe without assigning treatment) · Lead sponsor: ReCor Medical, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Paradise Ultrasound Renal Denervation Treatment
What this trial 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. 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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
43 locations listed across 22 US states.
- Tibor Rubin VA Medical Center - Long Beach, California, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Sutter Institute for Medical Research - Sacramento, California, United States
- UC Davis Medical Center - Sacramento, California, United States
- Pacific Heart Institute - Santa Monica, California, United States
- Rocky Mountain Regional VAMC - Aurora, Colorado, United States
- Medical Center of the Rockies - Loveland, Colorado, United States
- Bridgeport Hosptial - Bridgeport, Connecticut, United States
- The Cardiac & Vascular Institute - Gainesville, Florida, United States
- University of Miami Health System - Miami, Florida, United States
- Ascension Sacred Heart - Pensacola, Florida, United States
- Tampa Cardiovascular Interventions and Research - Tampa, Florida, United States
- Wellstar Kennestone Hospital - Marietta, Georgia, United States
- Southern Illinois University, Memorial Medical Center - Springfield, Illinois, United States
- Ascension via Christi St. Francis - Wichita, Kansas, United States
- Touro Infirmary - New Orleans, Louisiana, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- The Brigham and Women's Hospital - Boston, Massachusetts, United States
- Henry Ford Health - Detroit, Michigan, United States
- Henry Ford St. John Hospital - Detroit, Michigan, United States
- Metropolitan Heart & Vascular Institute - Coon Rapids, Minnesota, United States
- Saint Luke's Mid America Heart Institute - Kansas City, Missouri, United States
- Virtua Health - Marlton, New Jersey, United States
- Albany Medical Center - Albany, New York, United States
- NewYork-Presbyterian Brooklyn Methodist Hospital - Brooklyn, New York, United States
- University at Buffalo - Buffalo, New York, United States
- NYU Langone Health - Bellevue Hosptial - New York, New York, United States
- Columbia University Medical Center/New York Presbyterian Hospital - New York, New York, United States
- Stony Brook Medicine - Stony Brook, New York, United States
- University of North Carolina at Chapel Hill School of Medicine - Chapel Hill, North Carolina, United States
- Durham VA Health System - Durham, North Carolina, United States
- UPMC Harrisburg - Harrisburg, Pennsylvania, United States
- Penn Medicine - Phildelphia, Pennsylvania, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- Prisma Health Richland Hospital - Columbia, South Carolina, United States
- Spartanburg Regional Medical Center - Spartanburg, South Carolina, United States
- Ascension Saint Thomas - Nashville, Tennessee, United States
- Ascension Seton - Austin, Texas, United States
- Dallas VAMC - Dallas, Texas, United States
- TCR Institute - Kingwood, Texas, United States
- St. Mark's Hospital - Salt Lake City, Utah, United States
- Inova Fairfax Hospital - Fairfax, Virginia, United States
- Swedish Medical Center - Seattle, Washington, United States