What is the Purpose of this Study?
The purpose of this study is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System in patients who are unable to lower their blood pressure with lifestyle changes and medication. The Paradise Ultrasound Renal Denervation System is comprised of a catheter, cable, balloon, and generator; it is approved by the U.S. Food and Drug Administration. In some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys are overactive, which may cause high blood pressure. Renal denervation is a procedure during which a catheter is placed inside these blood vessels; heat is used to disable nerve activity and lower blood pressure. Study procedures also include questionnaires, physical exams, and imaging tests. Participants will be asked to record their blood pressure at home with a provided blood pressure monitor. Through this study, researchers hope to better understand the long-term safety and effectiveness of treatment with the Paradise System.
Eligibility
- * 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
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Global Paradise System US Post Approval Study