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Global Paradise System US Post Approval Study

NCT06297291 · ReCor Medical, Inc.
In plain English

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Official title
The Global Paradise® System US Post Approval Study (US GPS)
About this study
In some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys are overactive, which may cause blood pressure to increase. Renal denervation is a procedure where a catheter is placed inside these blood vessels and heat is used to ablate and disable the nerve activity and lower blood pressure. Hypertension patients that meet the study eligibility criteria will undergo the ultrasound renal denervation procedure using the Paradise System and will be asked to measure their blood pressure throughout the study, including measuring BP out of the clinic setting using a home BP monitoring device provided by the study. Participants will also be asked to answer some questions about their quality of life, health, sleep and emotions. Additional demographic data, medical history and socio-economic data may also be collected. As part of study participation, everyone who receives ultrasound renal denervation will be seen by the study doctor and designated study team members for 60 months (5 years) following the procedure.
Eligibility criteria
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
Study design
Enrollment target: 1000 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-06-28
Estimated completion: 2031-07
Last updated: 2026-04-13
Interventions
Device: Paradise Ultrasound Renal Denervation Treatment
Primary outcomes
  • Co-Primary Endpoint #1: Group Mean BP reduction (Baseline to 3-months post-procedure)
  • Co-Primary Endpoint #2: Subject Responder (Baseline to 3-months post-procedure)
Sponsor
ReCor Medical, Inc. · industry
Contacts & investigators
ContactHelen Reeve-Stoffer, PhD · contact · hreeve-stoffer@recormedical.com · +1 650-912-9032
ContactLiz Sheehan · contact · Liz.Sheehan@recormedical.com
All locations (38)
Sutter Institute for Medical ResearchRecruiting
Sacramento, California, United States
UC Davis Medical CenterRecruiting
Sacramento, California, United States
Pacific Heart InstituteRecruiting
Santa Monica, California, United States
Rocky Mountain Regional VAMCRecruiting
Aurora, Colorado, United States
Bridgeport HosptialRecruiting
Bridgeport, Connecticut, United States
The Cardiac & Vascular InstituteRecruiting
Gainesville, Florida, United States
University of Miami Health SystemRecruiting
Miami, Florida, United States
Ascension Sacred HeartRecruiting
Pensacola, Florida, United States
Tampa Cardiovascular Interventions and ResearchRecruiting
Tampa, Florida, United States
Southern Illinois University, Memorial Medical CenterRecruiting
Springfield, Illinois, United States
Ascension via Christi St. FrancisRecruiting
Wichita, Kansas, United States
Touro InfirmaryRecruiting
New Orleans, Louisiana, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
The Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
Metropolitan Heart & Vascular InstituteRecruiting
Coon Rapids, Minnesota, United States
Saint Luke's Mid America Heart InstituteRecruiting
Kansas City, Missouri, United States
Virtua HealthRecruiting
Marlton, New Jersey, United States
Albany Medical CenterRecruiting
Albany, New York, United States
NewYork-Presbyterian Brooklyn Methodist HospitalRecruiting
Brooklyn, New York, United States
University at BuffaloRecruiting
Buffalo, New York, United States
NYU Langone Health - Bellevue HosptialRecruiting
New York, New York, United States
Columbia University Medical Center/New York Presbyterian HospitalRecruiting
New York, New York, United States
Stony Brook MedicineRecruiting
Stony Brook, New York, United States
University of North Carolina at Chapel Hill School of MedicineRecruiting
Chapel Hill, North Carolina, United States
Durham VA Health SystemRecruiting
Durham, North Carolina, United States
UPMC HarrisburgRecruiting
Harrisburg, Pennsylvania, United States
Penn MedicineRecruiting
Phildelphia, Pennsylvania, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Prisma Health Richland HospitalRecruiting
Columbia, South Carolina, United States
Spartanburg Regional Medical CenterRecruiting
Spartanburg, South Carolina, United States
Ascension Saint ThomasRecruiting
Nashville, Tennessee, United States
Ascension SetonRecruiting
Austin, Texas, United States
Dallas VAMCRecruiting
Dallas, Texas, United States
TCR InstituteRecruiting
Kingwood, Texas, United States
St. Mark's HospitalRecruiting
Salt Lake City, Utah, United States
Inova Fairfax HospitalRecruiting
Fairfax, Virginia, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Global Paradise System US Post Approval Study · TrialPath