Global Paradise System US Post Approval Study
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.
Conditions:
🦠 Hypertension 🦠 Cardiovascular Diseases 🦠 Vascular Diseases
🗓️ Study Start (Actual) 28 June 2024
🗓️ Primary Completion (Estimated) September 2026
✅ Study Completion (Estimated) July 2031
👥 Enrollment (Estimated) 1000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Bridgeport, Connecticut, United States
📍 Gainesville, Florida, United States
📍 Marlton, New Jersey, United States
📍 Durham, North Carolina, United States
📍 Kingwood, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 February 2024
  • First Submitted that Met QC Criteria 29 February 2024
  • First Posted 7 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 July 2024
  • Last Update Posted 29 July 2024
  • Last Verified July 2024