Global Paradise System US Post Approval Study

Launched by RECOR MEDICAL, INC. · Feb 29, 2024

Keywords

ClinConnect Summary

The Global Paradise System US Post Approval Study is looking to understand how well the Paradise Ultrasound Renal Denervation System works for patients with high blood pressure who have not had success lowering it through lifestyle changes or medications. This system, which has been approved by the FDA, involves a small tube (catheter) that is used to treat the kidneys, helping to control blood pressure levels. The study is currently recruiting participants aged 65 to 74 who have a history of high blood pressure and are currently taking medication for it.

To be eligible, participants need to have a high blood pressure reading at their doctor’s office and from home. They should also have healthy kidney function. However, some individuals, such as those under 18, pregnant women, or those with certain kidney issues, will not be able to take part in the study. If you join, you can expect to receive the treatment and be monitored over time to see how well it works for you and if there are any safety concerns. This trial aims to gather important information that could help improve care for others with high blood pressure in the future.

Gender

ALL

Eligibility criteria

• 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