The objective of the Global ParadiseĀ® 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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Co-Primary Endpoint #1: Group Mean BP reduction
Timeframe: Baseline to 3-months post-procedure
Co-Primary Endpoint #2: Subject Responder
Timeframe: Baseline to 3-months post-procedure