ReCor Medical Paradise System in Clinical Hypertension

What is the Purpose of this Study?

The purpose of this study is to continue to collect data on the safety and effectiveness of a medical device called the Paradise Ultrasound Renal Denervation System (also called the Paradise System) in patients who are known to have uncontrolled hypertension despite taking blood pressure-lowering medications. Previous research supports the continued study of the Paradise System. This study will collect additional safety data and efficacy data (i.e., the blood pressure lowering effect) in patients with uncontrolled hypertension. All patients who meet enrollment criteria will receive renal denervation treatment in this non-randomized study. Renal denervation is a minimally invasive procedure in which a catheter is used to send ultrasound or heat energy to the renal arteries. Results from the study may be used to help the U.S. Food and Drug Administration (FDA) determine whether the device should be approved in the United States.


Eligibility

  • Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent
  • Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

RADIANCE Continued Access Protocol A study of the ReCor Medical Paradise System in Clinical Hypertension

Study Details
Disease Type/Condition

Hypertension

Principal Investigator

Rader, Florian

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002501

ClinicalTrials.gov ID

NCT05017935

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Hypertension

Principal Investigator

Rader, Florian

Age Group

Adult

Phase

N/A

IRB Number

CLN-0932

ClinicalTrials.gov ID

NCT05017935

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org