Long-term study of an ultrasound device for high blood pressure
Follows adults with high blood pressure treated with an ultrasound kidney nerve device.
Key facts
- Who runs it
- ReCor Medical, Inc.
- Where
- Basel, Geneva, and Lucerne, SwitzerlandSee the 3 sitesAlso in 8 other countries, 52 sites
- Trial code
- Registry title
- The "Global Paradise System" Registry
- Status
- Recruiting
- People taking part
- 3,000 people, planned
- Started
- 13 Jan 2022
- Expected to end
- 31 Dec 2031
- Type of study
- Observational
- Treatments tested
- The Paradise Ultrasound Renal Denervation System
- Record updated
- 4 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high blood pressure who are candidates for renal denervation with the Paradise System, or who had it in the last 6 months.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- High blood pressure (hypertension); the doctor judges the person a candidate for renal denervation.
- Earlier treatment
- Either a candidate for renal denervation with the Paradise System, or already treated with the Paradise Ultrasound Renal Denervation System within the 6 months before consent.
Main reasons for not taking part
- Stented renal artery
- Pregnant
- Known allergy to contrast medium
- Renal artery diameter under 3 mm or over 8 mm
- Renal artery stenosis of any origin over 30%
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Switzerland
Also in 8 other countries, 52 sites
- Universitätsspital BaselBasel, SwitzerlandContact: Lucas Lauder, Dr. (principal investigator)Taking people
- HUG Geneve SwitzerlandGeneva, SwitzerlandContact: Laetitia GallegoTaking people
- Heart Center Lucerne -Luzerner KantonsspitalLucerne, SwitzerlandContact: Brigitta MehmannTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Renal Denervation Treatment
Patients candidate for treatment or already treated within 6 months prior to consent, as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System, will be enrolled in this single arm registry.
Treatment: The Paradise Ultrasound Renal Denervation System
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The "Global Paradise® System" Registry
- Plain-language title
- Long-term study of an ultrasound device for high blood pressureGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 4 June 2026