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Evaluating the Paradise System for treating uncontrolled high blood pressure

The Global Paradise® System US Post Approval Study (US GPS)

Observational ReCor Medical, Inc. · NCT06297291

This study is testing whether a new ultrasound treatment can help people with high blood pressure who haven't been able to control it with diet or medications.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorReCor Medical, Inc. Industry-sponsored
Locations39 sites (Sacramento, California and 38 other locations)
Trial IDNCT06297291 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with a documented history of hypertension who have not responded adequately to antihypertensive medications.

Not a fit: Patients with certain renal anatomical issues, those under 18 years old, pregnant women, or individuals with transplanted kidneys will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with resistant hypertension, potentially leading to better blood pressure control and improved quality of life.

How similar studies have performed: Previous studies on renal denervation have shown promise, indicating that this approach may be effective for managing resistant hypertension.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Sacramento, California and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HypertensionCardiovascular DiseasesVascular DiseasesBlood PressureUncontrolled HypertensionEssential HypertensionResistant HypertensionRenal Denervation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.