The RADIANCE II Pivotal Study A Study of the ReCor Medical PARADISE System in Stage II Hypertension

Brief description of study

The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension. The results of this study will be used to help the Food and Drug Administration (FDA) determine if the device should be approved in the USA. All subjects will be asked to stop taking hypertension medication for approximately 16 weeks. This covers the evaluation time before the procedure until 2 months following the procedure. All patients that remain eligible after a period of evaluation, will have a procedure. During the procedure, subjects are randomly chosen (assigned by chance, like the flip of a coin) to receive renal denervation or to only have a diagnostic procedure that looks at the blood vessels leading to the kidneys (control).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Medical Research
Age: - 99 Years
Gender: All

Updated on 12 May 2021. Study ID: 844948

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