The Global Paradise® System US Post Approval Study (US GPS)
ReCor Medical, Inc.
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.
Description
In some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys are overactive, which may cause blood pressure to increase. Renal denervation is a procedure where a catheter is placed inside these blood vessels and heat is used to ablate and disable the nerve activity and lower blood pressure. Hypertension patients that meet the study eligibility criteria will undergo the ultrasound renal denervation procedure using the Paradise System and will be asked to measure their blood pressure throughout the study, including measuring BP out of the clinic set…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * 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: * Patient…
Interventions
- DeviceParadise Ultrasound Renal Denervation Treatment
The Paradise Ultrasound Renal Denervation System (Paradise Ultrasound RDN) is an FDA-approved catheter-based system to treat hypertension by ablating the nerves around the renal arteries, disrupting the overactive sympathetic nerves that can cause high blood pressure. The Paradise procedure uses ultrasound energy to calm the nerves near the kidneys to help lower blood pressure. Treatment is usually done in an outpatient setting and typically takes about an hour to perform. As a part of the treatment, a small flexible tube (catheter) is guided into the blood vessels near the kidneys and 7 seconds of ultrasound energy is applied 2-3 times. Both sides are treated and then the catheter is removed, leaving nothing behind. After the procedure, some people go home the same day or some stay overnight.
Locations (39)
- Sutter Institute for Medical ResearchSacramento, California
- UC Davis Medical CenterSacramento, California
- Pacific Heart InstituteSanta Monica, California
- Rocky Mountain Regional VAMCAurora, Colorado
- Bridgeport HosptialBridgeport, Connecticut
- The Cardiac & Vascular InstituteGainesville, Florida