At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- The Paradise Ultrasound Renal Denervation System (device)
- How long the study runs
- Study runs about 119 months (dates as stated)
- About the drug or intervention
- The Paradise Ultrasound Renal Denervation System — device: The CE-marked and commercially available ReCor Medical Paradise Ultrasound Renal Denervation System (Paradise System) is a catheter-based device designed to use ultrasound energy to thermally ablate the nerves surrounding the renal artery and serving the kidney.
- Patient visit burden
- Not specified by the sponsor
In plain English
This registry, run by ReCor Medical, Inc., collects information from people with high blood pressure (hypertension) who are having a treatment called renal denervation with the Paradise Ultrasound Renal Denervation System, or who had it in the last 6 months. The treatment is not described further in the data provided.
Who can take part
- Adults aged 18 or over
- Able to give informed consent (agree to take part after being told about the study)
- A doctor thinks renal denervation with the Paradise System is suitable for them, OR they were treated with the Paradise Ultrasound Renal Denervation System in the 6 months before consenting
Who may not be able to
- Under 18
- Pregnant
- A stent (small tube) in the renal artery (the blood vessel to the kidney)
- Known allergy to contrast medium (a dye used in scans)
- Renal arteries that are narrower than 3 mm or wider than 8 mm
- Fibromuscular disease (FMD) in the renal artery
- A bulge (aneurysm) in the renal artery
- Narrowing of the renal artery by more than 30%
- Narrowing in the iliac or femoral artery (blood vessels in the hip or leg) that stops the Paradise catheter being inserted
What taking part involves
- • Not stated — ask the trial team
Time commitment: Visits, duration and what taking part involves: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 3,000
- Started
- 2022-01-13
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for hypertension
- • Clinical study - 3,000 participants
- • The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hypertension
Where?
- • Bournemouth - Royal Bournemouth Hospital, Bournemoth
- • Canterbury - Kent and Canterbury Hospital, Canterbury
- • Cardiff - University Hospital Wales, Cardiff
- • Dudley - Russells Hall Hospital
- • +7 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Renal denervation (RDN) by way of ultrasound is is a catheter-based technique to deliver ultrasound energy to thermally ablate and disrupt the renal efferent and afferent sympathetic nerves while sparing the renal arterial wall. The ReCor Medical ParadiseTM Ultrasound Renal Denervation System (ParadiseTM System) is a product admitted for clinical use implementing this technique. The goal of ultrasound renal denervation (ultrasound RDN) is to achieve a reduction in sympathetic over-activity with the resultant effect of reducing systemic arterial blood pressure (BP), and mitigating resultant end organ damage. With the expected increase in the number of patients to be treated in clinical practice with ultrasound RDN, and the importance of collecting real-world data on the long-term use and performance of ultrasound RDN through the use of the ParadiseTM System in a large population of patients, the Global ParadiseTM System (GPS) Registry has been set-up
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Appropriately signed and dated agreement to take part
- ✓Age ≥18 at time of consent
Who cannot take part
- ✗Patients who meet any of the contraindications listed in the Instructions for Use will be excluded.
- ✗The contraindications are:
- ✗Stented kidney artery
- ✗Less than 18 years of age
- ✗Pregnant
See the full criteria
Where Is This Study? (11 UK sites)
Royal Bournemouth Hospital, Bournemoth
Bournemouth, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200Kent and Canterbury Hospital, Canterbury
Canterbury, United Kingdom
University Hospital Wales, Cardiff
Cardiff, United Kingdom
Russells Hall Hospital
Dudley, United Kingdom
Queen Elizabeth Hospital, Glasgow
Glasgow, United Kingdom
Castle Hill Hospital Hull
Hull, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Hammersmith Hospital (Imperial College Healthcare NHS Trust)
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom
St Thomas' Hospital
London, United Kingdom
WHRC - Barts Health, London
London, United Kingdom
Freeman Hospital, Newcastle
Newcastle, United Kingdom
How to Get in Touch
Helen Reeve-Stoffer, PhD
Sponsor contactCONTACT
Hajime Arnold
Sponsor contactCONTACT