The RADIANCE-HTN Clinical Study-TRIO COHORT: A Study of the ReCor Medical PARADISE® System in Clinical Hypertension
Recruiting
18 years - 90 years
All
Phase
N/A
10 participants needed
1 Location
Brief description of study
High blood pressure is also known as “hypertension.” 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. Renal denervation utilizing the Paradise system uses therapeutically heated ultrasound energy to disrupt nerve activity by either disabling or destroying the nerves that provide signals to the kidney and may lower blood pressure.
Detailed description of study
People with high blood pressure may be on blood pressure lowering medications or they may not be on any medication. There are two groups in the study – the SOLO Cohort and the TRIO Cohort. The results of this study may be used to help the Food and Drug Administration (FDA) determine if the device should be approved in the USA.
The SOLO Cohort has completed enrollment and preliminary results are available. The TRIO Cohort is still enrolling patients. You are being considered for enrollment in the TRIO cohort
The Paradise System is a medical device made by a company called ReCor Medical Inc., based in Palo Alto, California in the USA. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven’t been approved by the FDA.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: hypertension
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Age: 18 years - 90 years
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Gender: All
Updated on
19 Feb 2024.
Study ID: 831736
