Recruiting

Global Paradise System US Post Approval Study

The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment…

ClinicalTrials.gov IDNCT06297291

PhaseNot Applicable

Enrollment1000

SponsorReCor Medical, Inc.

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Hypertension, Cardiovascular Diseases, Vascular Diseases

About this study

Interventions

Device: Paradise Ultrasound Renal Denervation Treatment — The Paradise Ultrasound Renal Denervation System (Paradise Ultrasound RDN) is an FDA-approved catheter-based system to treat hypertension by ablating the nerves around the renal arteries, disrupting the overactive sympathetic nerves that can cause high blood pressure. The Paradise procedure uses ultrasound energy to calm the nerves near the kidneys to help lower blood pressure. Treatment is usually done in an outpatient setting and typically takes about an hour to perform. As a part of the treatment, a small flexible tube (catheter) is guided into the blood vessels near the kidneys and 7 seconds of ultrasound energy is applied 2-3 times. Both sides are treated and then the catheter is removed, leaving nothing behind. After the procedure, some people go home the same day or some stay overnight.

Primary outcomes

Co-Primary Endpoint #1: Group Mean BP reduction (Baseline to 3-months post-procedure)
Co-Primary Endpoint #2: Subject Responder (Baseline to 3-months post-procedure)

Eligibility information

Inclusion Criteria: * Signed and dated study informed consent * Documented history of hypertension * Documented history of prior or current antihypertensive medication(s) * Mean 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: * Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter * Patient under the age of 18 years old at the time of consent * Patient is pregnant * Patients with transplanted kidney * Presence of abnormal kidney (or secreting adrenal) tumors To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment: * Renal arteries with diameter \< 3mm and \> 8mm * Renal artery with fibromuscular dysplasia (FMD) * Stented renal artery * Renal artery aneurysm * Renal artery diameter stenosis \>30% * Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter

Study locations

Tibor Rubin VA Medical Center, Long Beach, California 90822 United States
Cedars-Sinai Medical Center, Los Angeles, California 90048 United States
Sutter Institute for Medical Research, Sacramento, California 95816 United States
UC Davis Medical Center, Sacramento, California 95817 United States
Pacific Heart Institute, Santa Monica, California 90404 United States
Rocky Mountain Regional VAMC, Aurora, Colorado 80045 United States
Medical Center of the Rockies, Loveland, Colorado 80538 United States
Bridgeport Hosptial, Bridgeport, Connecticut 06610 United States
The Cardiac & Vascular Institute, Gainesville, Florida 32605 United States
University of Miami Health System, Miami, Florida 33136 United States

Showing 10 of 43 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.