Global Paradise System US Post Approval Study
(US GPS Trial)

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: ReCor Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

I have signed and dated the consent form for this study.

I have a documented history of high blood pressure.

I have taken medication for high blood pressure.

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Treatment Details

Participant Groups

2Treatment groups

Experimental Treatment

Group I: RADIANCE CAP TransferExperimental Treatment0 Interventions

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.

Group II: Prospective Ultrasound Renal Denervation TreatmentExperimental Treatment1 Intervention

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.