An observational study in Hypertension, sponsored by ReCor Medical, Inc.. Recruiting at 55 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by ReCor Medical, Inc. (part of Otsuka Holdings Co., Ltd.) · Observational
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.
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
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →ReCor Medical, Inc. is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The GPS Registry will collect both retrospective and prospective data in patients treated as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who meet any of the listed in the Instructions for Use will be excluded.
The contraindications are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: The Paradise Ultrasound Renal Denervation System
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.
Incidence of all-cause mortality
Rate of mortality attributed to any causality as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of new onset end-stage renal disease
eGFR\<15 mL/min/m2 or need for renal replacement therapy as per site standard practice
Time frame: Through 5 Years post-procedure
Significant decline in renal function
≥50% increase in serum creatinine (mg/dL)
Time frame: Through 5 Years post-procedure
New renal artery stenosis
\>70% confirmed by CTA/MRA as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of renal artery perforation or dissection requiring an invasive intervention
Rate of renal artery perforation or dissection attributed to any causality as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of major vascular complications (e.g, clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion as per site standard practice
Rate of renal major vascular complications attributed to any causality as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of hospitalization for hypertensive crisis or symptomatic hypotension
Hospitalization for hypertensive crisis or symptomatic hypotension as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF)
Hospitalization for major cardiovascular- or hemodynamic-related events as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of new onset stroke, TIA or CVA
Incidence of new onset stroke, TIA or CVA as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of acute myocardial infarction
Incidence of acute myocardial infarction as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of any coronary revascularization
Rate of any coronary revascularization as per site standard practice.
Time frame: Through 5 Years post-procedure
Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment
Rate of reduction in average home systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice.
Time frame: Through 5 Years post-procedure
Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment
Rate of reduction in average office systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice.
Time frame: Through 5 Years post-procedure
Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment
Rate of reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Rate of incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Rate of incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Time frame: Through 5 Years post-procedure
Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Rate of incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Time frame: Through 5 Years post-procedure
Percentage of subjects who are controlled according to current guidelines
Percentage of subjects who are controlled according to current guidelines as per site standard practice.
Time frame: Through 5 Years post-procedure
Change in office/home/ambulatory pulse pressure in mmHg
Rate change in office/home/ambulatory pulse pressure in mmHg as per site standard practice.
Time frame: Through 5 Years post-procedure
Change in office/home/ambulatory heart rate in bpm
Change in office/home/ambulatory heart rate in bpm as per site standard practice.
Time frame: Through 5 Years post-procedure
Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications
Rate percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications per site standard practice.
Time frame: Through 5 Years post-procedure
Analysis of quarterly Home BP in mmHg
Analysis of quarterly Home BP in mmHg as per site standard practice.
Time frame: Through 5 Years post-procedure
Change from enrollment in quality of life scores as measured by the 12-item Short Form Health Survey (SF-12)
The 12-item Short Form Health Survey (SF-12) is a measure of health-related quality-of-life. Scores for each domain range from 0 to 100, with a higher score indicating a more favorable health state.
Time frame: Through 5 Years post-procedure
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Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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