Global Paradise System US Post Approval Study

Conditions

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Paradise Ultrasound Renal Denervation Treatment — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Jun 28, 2024

Status verified

May 2026

Primary completion

Sep 30, 2026

Completion

Jul 31, 2031

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: Prospective Ultrasound Renal Denervation Treatment
  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.
• Arm: RADIANCE CAP Transfer
  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.

Primary Outcome Measure

Co-Primary Endpoint #1: Group Mean BP reduction [ Time Frame: Baseline to 3-months post-procedure ]

Central Contacts

• Helen Reeve-Stoffer, PhD
  +1 650-912-9032
  [email protected]
• Liz Sheehan
  [email protected]

Locations (39)

Find similar trials in Sacramento, CA

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