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Global Paradise System US Post Approval Study
The Global Paradise® System US Post Approval Study (US GPS)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the 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.
What is being tested
- Paradise Ultrasound Renal Denervation Treatment (device)
Sponsor: ReCor Medical, Inc. · Participants: 1,000 · Started: Jun 28, 2024
Contact the study team
- Helen Reeve-Stoffer, PhD · Phone: +1 650-912-9032
Official record on ClinicalTrials.gov — NCT06297291
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.