RecruitingHypertensionCardiovascular DiseasesVascular Diseases

Global Paradise System US Post Approval Study

Eligible age

18+ yrs

Accepts

All genders

Locations

22 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

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)
✓ 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.

You may not qualify if…

✕ 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