Clinical Trial

Global Paradise System US Post Approval Study

Study acronym: US GPS
Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 39 -> 43 locations 2026-08-13
notable Trial sites expanded: 34 -> 38 locations 2026-04-14
Trial Details
NCT Number NCT06297291
Lead Sponsor ReCor Medical, Inc.
Conditions Hypertension, Cardiovascular Diseases, Vascular Diseases
Enrollment 1,000 participants
Start Date 2024-06-28
Primary Completion 2026-09 (estimated)
Study Completion 2031-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-12