Long-term study of an ultrasound device for high blood pressure
Follows adults with high blood pressure treated with an ultrasound kidney nerve device.
Plain-language title generated from the registry record
Registry title: The "Global Paradise System" Registry
Key facts
- Where
- Barcelona and Madrid, SpainSee the 2 sites
Where in Spain
- Hospital Universitario German Trias i PujolBarcelona, SpainNo longer taking part
- Hospital Clinico Universitario S.CarlosMadrid, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ReCor Medical, Inc.
- Trial code
- NCT05027685
- Record updated
- 4 June 2026
- Original description
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.Read full original descriptionShow less
The "Global Paradise® System" Registry
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.
Inclusion: Appropriately signed and dated informed consent; Age ≥18 at time of consent; Patient candidate for renal denervation with the Paradise System based on physician's assessment OR Patient treated with the Paradise Ultrasound Renal Denervation System within the 6 months prior to consent.
Exclusion: Known allergy to contrast medium; Renal artery with Fibromuscular (FMD) disease; Less than 18 years of age; Patients who meet any of the contraindications listed in the Instructions for Use will be excluded; The contraindications are:; Stented renal artery; Pregnant; Renal arteries diameter < 3 mm and > 8 mm; Renal artery aneurysm; Renal artery stenosis of any origin >30%; Iliac/femoral artery stenosis precluding insertion of the Paradise catheter.