Global Paradise System US Post Approval 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.
- EligibilityCriteria: 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 lacks appropriate renal anatomy for any treatment with the Paradise Catheter Patient under the age of 18 years old at the time of consent Patient is pregnant Patients with transplanted kidney Presence of abnormal kidney (or secreting adrenal) tumors  To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment:  Renal arteries with diameter < 3mm and > 8mm Renal artery with fibromuscular dysplasia (FMD) Stented renal artery Renal artery aneurysm Renal artery diameter stenosis >30% Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control BP will be identified from the general population by the enrolling center.  Subjects enrolled in the RADIANCE CAP study will be transferred to the US GPS study after completion of their 12-month follow-up visit in the RADIANCE CAP study, to complete the remainder of the long-term annual follow-up visits under the post approval study protocol. - SamplingMethod: Non-Probability Sample