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Global Paradise System US Post Approval Study

Recruitingn/aAges 18 Years - anyAllReCor Medical, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: Patients who meet the following will be excluded from participation: * Subject under the age of 18 years old at the time of consent * 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.
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What it tests

  • Paradise Ultrasound Renal Denervation Treatment
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Where

46 sites
Tibor Rubin VA Medical Center
Long Beach, United States
Cedars-Sinai Medical Center
Los Angeles, United States
Sutter Institute for Medical Research
Sacramento, United States
UC Davis Medical Center
Sacramento, United States
Pacific Heart Institute
Santa Monica, United States
Rocky Mountain Regional VAMC
Aurora, United States
Medical Center of the Rockies
Loveland, United States
Bridgeport Hosptial
Bridgeport, United States

…and 38 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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