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NCT Number: NCT05027685

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.

Recruiting

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna,, Vienna, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

Patients who meet any of the contraindications listed in the Instructions for Use will be excluded.

The contraindications are:

  • Stented renal artery
  • Less than 18 years of age
  • Pregnant
  • Known allergy to contrast medium
  • Renal arteries diameter < 3 mm and > 8 mm
  • Renal artery with Fibromuscular (FMD) disease
  • Renal artery aneurysm
  • Renal artery stenosis of any origin >30%
  • Iliac/femoral artery stenosis precluding insertion of the Paradise catheter

Treatment and study plan

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.

Primary outcomes

  1. Incidence of all-cause mortality

    Time frame: Through 5 Years post-procedure

    Rate of mortality attributed to any causality as per site standard practice.

  2. Incidence of new onset end-stage renal disease

    Time frame: Through 5 Years post-procedure

    eGFR<15 mL/min/m2 or need for renal replacement therapy as per site standard practice

  3. Significant decline in renal function

    Time frame: Through 5 Years post-procedure

    ≥50% increase in serum creatinine (mg/dL)

  4. New renal artery stenosis

    Time frame: Through 5 Years post-procedure

    >70% confirmed by CTA/MRA as per site standard practice.

  5. Incidence of renal artery perforation or dissection requiring an invasive intervention

    Time frame: Through 5 Years post-procedure

    Rate of renal artery perforation or dissection attributed to any causality as per site standard practice.

  6. 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

    Time frame: Through 5 Years post-procedure

    Rate of renal major vascular complications attributed to any causality as per site standard practice.

  7. Incidence of hospitalization for hypertensive crisis or symptomatic hypotension

    Time frame: Through 5 Years post-procedure

    Hospitalization for hypertensive crisis or symptomatic hypotension as per site standard practice.

  8. Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF)

    Time frame: Through 5 Years post-procedure

    Hospitalization for major cardiovascular- or hemodynamic-related events as per site standard practice.

  9. Incidence of new onset stroke, TIA or CVA

    Time frame: Through 5 Years post-procedure

    Incidence of new onset stroke, TIA or CVA as per site standard practice.

  10. Incidence of acute myocardial infarction

    Time frame: Through 5 Years post-procedure

    Incidence of acute myocardial infarction as per site standard practice.

  11. Incidence of any coronary revascularization

    Time frame: Through 5 Years post-procedure

    Rate of any coronary revascularization as per site standard practice.

  12. Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment

    Time frame: Through 5 Years post-procedure

    Rate of reduction in average home systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice.

  13. Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment

    Time frame: Through 5 Years post-procedure

    Rate of reduction in average office systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice.

  14. Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment

    Time frame: Through 5 Years post-procedure

    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.

  15. Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg

    Time frame: Through 5 Years post-procedure

    Rate of incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.

  16. Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg

    Time frame: Through 5 Years post-procedure

    Rate of incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.

  17. Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg

    Time frame: Through 5 Years post-procedure

    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.

  18. Percentage of subjects who are controlled according to current guidelines

    Time frame: Through 5 Years post-procedure

    Percentage of subjects who are controlled according to current guidelines as per site standard practice.

  19. Change in office/home/ambulatory pulse pressure in mmHg

    Time frame: Through 5 Years post-procedure

    Rate change in office/home/ambulatory pulse pressure in mmHg as per site standard practice.

  20. Change in office/home/ambulatory heart rate in bpm

    Time frame: Through 5 Years post-procedure

    Change in office/home/ambulatory heart rate in bpm as per site standard practice.

  21. Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications

    Time frame: Through 5 Years post-procedure

    Rate percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications per site standard practice.

  22. Analysis of quarterly Home BP in mmHg

    Time frame: Through 5 Years post-procedure

    Analysis of quarterly Home BP in mmHg as per site standard practice.

  23. Change from enrollment in quality of life scores as measured by the 12-item Short Form Health Survey (SF-12)

    Time frame: Through 5 Years post-procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hajime Arnold

CONTACT

[email protected]

+1 650 912 9023

Helen Reeve-Stoffer, PhD

CONTACT

[email protected]

+44 (0) 794 774 8006

Sponsors and collaborators

Lead sponsor

ReCor Medical, Inc.

Industry

Registry information

Official study title

The "Global Paradise® System" Registry

Acronym: GPSRegistry

Important dates

Study start
2022
Primary completion
2030
Study completion
2031
First posted
Aug 30, 2021
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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