An observational study in Hypertension, Cardiovascular Diseases and Vascular Diseases, sponsored by ReCor Medical, Inc.. Recruiting at 43 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by ReCor Medical, Inc. · Observational
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 with the Paradise System for patients with high blood pressure.
In some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys are overactive, which may cause blood pressure to increase. Renal denervation is a procedure where a catheter is placed inside these blood vessels and heat is used to ablate and disable the nerve activity and lower blood pressure.
Hypertension patients that meet the study eligibility criteria will undergo the ultrasound renal denervation procedure using the Paradise System and will be asked to measure their blood pressure throughout the study, including measuring BP out of the clinic setting using a home BP monitoring device provided by the study. Participants will also be asked to answer some questions about their quality of life, health, sleep and emotions. Additional demographic data, medical history and socio-economic data may also be collected. As part of study participation, everyone who receives ultrasound renal denervation will be seen by the study doctor and designated study team members for 60 months (5 years) following the procedure.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →ReCor Medical, Inc. is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control BP will be identified from the general population by the enrolling center.
Subjects enrolled in the RADIANCE CAP study will be transferred to the US GPS study after completion of their 12-month follow-up visit in the RADIANCE CAP study, to complete the remainder of the long-term annual follow-up visits under the post approval study protocol.
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:
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:
Hypertension patients that meet the eligibility criteria for treatment with Recor Medical Paradise Ultrasound Renal Denervation System will be enrolled and followed post-procedure for 5 years.
Device: Paradise Ultrasound Renal Denervation Treatment
Subjects enrolled in the RADIANCE Continued Access Protocol (CAP) study that are still active and have already completed their post-procedure 12-month follow-up visit are invited to participate in US GPS for long-term annual follow-up visits. These subjects will have already received the ultrasound Renal Denervation treatment under the RADIANCE CAP protocol and will not receive the procedure under the US GPS protocol.
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.
Also known as: Paradise Ultrasound RDN
Co-Primary Endpoint #1: Group Mean BP reduction
* Ho: Reduction in mean home systolic BP from baseline to 3 months \< 5 mmHg * Ha: Reduction in mean home systolic BP from baseline to 3 months ≥ 5 mmHg
Time frame: Baseline to 3-months post-procedure
Co-Primary Endpoint #2: Subject Responder
A subject will be defined as a responder if they achieve any of the following: * Control in home BP (defined as systolic BP \<130 mmHg) at 3 months and/or * Absolute reduction in home systolic BP fall ≥ 5 mmHg at 3 months and/or * Reduction in medication burden measured using defined daily dose (DDD)
Time frame: Baseline to 3-months post-procedure
Change in mean home systolic/diastolic BP in mmHg
Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Change in mean office systolic/diastolic BP in mmHg
Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Change in home and office pulse pressure
Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Change in the number and/or dosage and/or type of antihypertensive medications taken
Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Change in patient reported outcomes
Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Percentage of patients who are controlled as measured by various cut points of home BP (control to be assessed as both < 130 mmHg systolic and <135 mmHg systolic) office BP (control to also be assessed as <130 mmHg and <140 mmHg systolic)
Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Percentage of patients who demonstrate a reduction in home systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg
Time frame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
Percentage of patients who demonstrate a reduction in office systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg
Time frame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
Change in home and office heart rate
Time frame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
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ReCor Medical, Inc.