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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.
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

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Albany Medical Center
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AlbanyUnited StatesRecruiting
Rocky Mountain Regional VAMC
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AuroraUnited StatesRecruiting
Ascension Seton
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AustinUnited StatesRecruiting
St. Luke's Regional Medical Center
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BoiseUnited StatesRecruiting
The Brigham and Women's Hospital
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BostonUnited StatesRecruiting
Massachusetts General Hospital
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BostonUnited StatesRecruiting
Bridgeport Hosptial
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BridgeportUnited StatesRecruiting
NewYork-Presbyterian Brooklyn Methodist Hospital
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BrooklynUnited StatesRecruiting
University at Buffalo
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BuffaloUnited StatesRecruiting
University of North Carolina at Chapel Hill School of Medicine
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Chapel HillUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Prisma Health Richland Hospital
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ColumbiaUnited StatesRecruiting
Metropolitan Heart Vascular Institute
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Coon RapidsUnited StatesRecruiting
Dallas VAMC
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DallasUnited StatesRecruiting
Henry Ford St. John Hospital
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DetroitUnited StatesRecruiting
Henry Ford Health
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DetroitUnited StatesRecruiting
Durham VA Health System
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DurhamUnited StatesRecruiting
AHN Saint Vincent
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ErieUnited StatesRecruiting
Inova Fairfax Hospital
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FairfaxUnited StatesRecruiting
The Cardiac & Vascular Institute
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GainesvilleUnited StatesRecruiting
UPMC Harrisburg
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HarrisburgUnited StatesRecruiting
Saint Luke's Mid America Heart Institute
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Kansas CityUnited StatesRecruiting
TCR Institute
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KingwoodUnited StatesRecruiting
Tibor Rubin VA Medical Center
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Long BeachUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Medical Center of the Rockies
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LovelandUnited StatesRecruiting
Wellstar Kennestone Hospital
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MariettaUnited StatesRecruiting
Virtua Health
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MarltonUnited StatesRecruiting
University of Miami Health System
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MiamiUnited StatesRecruiting
Ascension Saint Thomas
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NashvilleUnited StatesRecruiting
Touro Infirmary
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New OrleansUnited StatesRecruiting
NYU Langone Health - Bellevue Hosptial
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New YorkUnited StatesRecruiting
Columbia University Medical Center/New York-Presbyterian Hospital
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New YorkUnited StatesRecruiting
Ascension Sacred Heart
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PensacolaUnited StatesRecruiting
Penn Medicine
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PhildelphiaUnited StatesRecruiting
WakeMed Health and Hospitals
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RaleighUnited StatesRecruiting
Sutter Institute for Medical Research
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SacramentoUnited StatesRecruiting
UC Davis Medical Center
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SacramentoUnited StatesRecruiting
St. Mark's Hospital
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Salt Lake CityUnited StatesRecruiting
Pacific Heart Institute
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Santa MonicaUnited StatesRecruiting
Swedish Medical Center
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SeattleUnited StatesRecruiting
Spartanburg Regional Medical Center
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SpartanburgUnited StatesRecruiting
Southern Illinois University, Memorial Medical Center
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SpringfieldUnited StatesRecruiting
Stony Brook Medicine
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Stony BrookUnited StatesRecruiting
Tampa Cardiovascular Interventions and Research
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TampaUnited StatesRecruiting
Ascension Via Christi St. Francis
Coordinator of this site? Confirm its status
WichitaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.