RecruitingHypertensionCardiovascular DiseasesVascular Diseases

Global Paradise System US Post Approval Study

Eligible age

18+ yrs

Accepts

All genders

Locations

23 states

Healthy volunteers

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About this 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 with the Paradise System for patients with high blood pressure.

Sponsor: ReCor Medical, Inc.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.