NCT06297291

Global Paradise System US Post Approval Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: ReCor Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypertension
• Cardiovascular Diseases
• Vascular Diseases

Interventions

Type	Name	Description
DEVICE	Paradise Ultrasound Renal Denervation Treatment	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.

Timeline

• Start date: 2024-06-28
• Primary completion: 2026-09-01
• Completion: 2031-07-01
• First posted: 2024-03-07
• Last updated: 2026-04-13

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated device study