Evaluating the Paradise System for treating uncontrolled high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Global Paradise System US Post Approval Study aims to assess the real-world effectiveness and safety of the Paradise Ultrasound Renal Denervation System in patients with hypertension who have not achieved adequate blood pressure control through lifestyle changes and medications. This observational study will involve participants undergoing the renal denervation procedure, followed by long-term monitoring of their blood pressure and quality of life over a period of five years. Data collected will include home blood pressure measurements, demographic information, and responses to health-related questionnaires to provide insights into the treatment's impact.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed and dated study informed consent
* Documented history of hypertension
* Documented history of prior or current antihypertensive medication(s)
* Baseline 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:

* Subject under the age of 18 years old at the time of consent
* Subject is pregnant prior to index procedure\^ \^ If a treated subject becomes pregnant after ultrasound RDN procedure, the subject will be followed for outcomes.

The ultrasound RDN procedure will be performed according to the IFU for the Paradise System and per the site's standard of care for interventional Procedures.

Where it's running

• Tibor Rubin VA Medical Center
  Long Beach, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Sutter Institute for Medical Research
  Sacramento, California, United States Recruiting
• UC Davis Medical Center
  Sacramento, California, United States Recruiting
• Pacific Heart Institute
  Santa Monica, California, United States Recruiting
• Rocky Mountain Regional VAMC
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Helen Reeve-Stoffer, PhD
• Email: hreeve-stoffer@recormedical.com
• Phone: +1 650-912-9032

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.