Global Paradise System US Post Approval Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Co-Primary Endpoint #1: Group Mean BP reduction — Baseline to 3-months post-procedure
  * Ho: Reduction in mean home systolic BP from baseline to 3 months \< 5 mmHg * Ha: Reduction in mean home systolic BP from baseline to 3 months ≥ 5 mmHg
• Co-Primary Endpoint #2: Subject Responder — Baseline to 3-months post-procedure
  A subject will be defined as a responder if they achieve any of the following: * Control in home BP (defined as systolic BP \<130 mmHg) at 3 months and/or * Absolute reduction in home systolic BP fall ≥ 5 mmHg at 3 months and/or * Reduction in medication burden measured using defined daily dose (DDD)

Trial sites (43)

+ 3 more sites — see the full list on the official registry below.

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