The RADIANCE-HTN Study: A Study of the ReCor Medical Paradise System in Clinical Hypertension (IRB no. 42715)
The purpose of this study is to evaluate whether an investigational medical device called the Paradise Renal Denervation System can lower high blood pressure in patients who are known to have hypertension. In some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys (renal arteries) are too active, which may cause high blood pressure. Renal denervation is a procedure where a catheter is placed inside these blood vessels (renal arteries) and creates heat to lower blood pressure. The Paradise Renal Denervation System consists of a catheter, balloon and generator. Researchers aim to demonstrate the efficacy and verify the safety of the Paradise System in two distinct populations of hypertensive patients.
Key Inclusion Criteria
- At least 18 years old and less than or equal to 75 years old
- Documented history of essential hypertension
- Suitable renal anatomy compatible with the renal denervation procedure
Key Exclusion Criteria
- Renal artery anatomy on either side that is ineligible for treatment
- Evidence of active infection within seven days of procedure
- Type 1 diabetes mellitus or uncontrolled Type 2 diabetes
Please see additional list of inclusion and exclusion criteria.
Florian Rader, MD