Health Trials

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Paradise Ultrasound Renal Denervation Treatment

Treatment groups

1,000 Participants
are divided into 2 treatment groups

Locations

39
California
Sutter Institute for Medical Research95816, Sacramento United States
UC Davis Medical Center95817, Sacramento United States
Pacific Heart Institute90404, Santa Monica United States
Colorado
Rocky Mountain Regional VAMC80045, Aurora United States

Sponsors and collaborators

ReCor Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov