The "Global Paradise System" Registry (GPSRegistry)

June 2, 2026 updated by: ReCor Medical, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Suspended
        • Medical University of Vienna,
      • Wels, Austria, 4600
        • Recruiting
        • Klinikum Wels-Grieskirchen GmbH
        • Principal Investigator:
          • Thomas Weber, Dr.
  • Belgium
      • Aalst, Belgium
        • Active, not recruiting
        • OLV Ziekenhuis Aalst
      • Brussels, Belgium
        • Active, not recruiting
        • UCL St Luc
      • Brussels, Belgium
        • Active, not recruiting
        • CHU Saint Pierre Brussels
      • Liège, Belgium, 4000
        • Active, not recruiting
        • Clinique CHS MontLégia
  • France
      • Bordeaux, France
        • Active, not recruiting
        • CHU Bordeaux Hôpital St. André
      • Marseille, France, 13354
        • Withdrawn
        • Assistance Publique Hôpitaux de Marseille (AP-HM)
      • Paris, France
        • Recruiting
        • HEGP (Hôpital Européen Georges Pompidouv) Paris
        • Contact:
          • V. Paquet
        • Contact:
          • C. Déan
        • Principal Investigator:
          • M. Azizi, Prof.
        • Sub-Investigator:
          • M. Sapoval, Prof.
      • Pau, France
        • Active, not recruiting
        • Centre Hospitalier de Pau
    • La Tronche
      • Grenoble, La Tronche, France, 38700
        • Active, not recruiting
        • CHU Grenoble Alpes - Hôpital Michallon
  • Germany
      • Ahrweiler, Germany, 53474
        • Suspended
        • Krankenhaus Maria Hilf Bad Neuenahr-Ahrweiler
      • Bad Krozingen, Germany
        • Recruiting
        • Universitäts-Herzzentrum Freiburg Bad Krozingen
        • Contact:
          • Olga Greb
        • Contact:
          • Jochen Strübin
        • Principal Investigator:
          • Elias Noory, Dr.
        • Sub-Investigator:
          • Thomas Zeller, Prof. Dr.
      • Berlin, Germany
        • Recruiting
        • Charite Universitatsmedizin Berlin Campus Benjamin Franklin
        • Contact:
        • Principal Investigator:
          • Georg Girke, Dr.
      • Coburg, Germany
        • Terminated
        • Klinikum Coburg GmbH
      • Cologne, Germany
        • Recruiting
        • Universitätsklinikum Köln
        • Contact:
          • Ana Heinrichs
        • Principal Investigator:
          • Marcel Halbach, Prof. Dr.
      • Detmold, Germany
        • Recruiting
        • Klinikum Lippe GmbH Detmold
        • Contact:
          • Angelika Göckeler
        • Contact:
          • Marion Denart
        • Principal Investigator:
          • Dirk-Udo Härtel, Dr.
      • Dresden, Germany
        • Recruiting
        • Herzzentrum Dresden GmbH Universitätsklinik
        • Contact:
          • Monika Famulla
        • Principal Investigator:
          • Robert Höllriegel, Dr.
      • Dresden, Germany
        • Recruiting
        • Städt. Klinikum Dresden (Standort Friedrichstadt)
        • Contact:
        • Principal Investigator:
          • Frank R. Heinzel, Prof.
      • Düsseldorf, Germany
        • Recruiting
        • Universitätsklinikum Düsseldorf
        • Contact:
          • Claudia Schmid, Dr.
        • Principal Investigator:
          • Johannes Stegbauer, Prof. Dr.
      • Erlangen, Germany
        • Recruiting
        • Universitätsklinikum Erlangen
        • Contact:
          • Ulrike Heinritz
        • Principal Investigator:
          • Roland Schmieder, Prof. Dr.
      • Frankfurt, Germany
        • Withdrawn
        • Cardiovasculäres Centrum (CVC) Frankfurt
      • Halle, Germany, 06120
        • Recruiting
        • Universitätsklinikum Halle (Saale), AöR
        • Principal Investigator:
          • Alexander Vogt, Dr.
      • Hamm, Germany
        • Active, not recruiting
        • St. Barbara-Klinik Hamm Heessen
      • Herne, Germany, 44625
      • Homburg, Germany, D-66421
        • Recruiting
        • University Clinic of Saarland - Homburg
        • Contact:
          • Christina Koch
        • Principal Investigator:
          • Michael Böhm, Prof. Dr.
      • Leipzig, Germany, D-04289
        • Recruiting
        • Herzzentrum Leipzig GmbH
        • Contact:
          • Ina Wagner
        • Principal Investigator:
          • Karl Fengler, Dr.
      • Lübeck, Germany
        • Recruiting
        • Sana Kliniken Lübeck GmbH
        • Contact:
          • Tanja Köllner
        • Contact:
          • Luise Blödorn
        • Principal Investigator:
          • Joachim Weil, Prof.
      • Mainz, Germany, 55131
        • Recruiting
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
        • Principal Investigator:
          • Philipp Lurz, Prof Dr Dr
      • Mainz, Germany
        • Recruiting
        • Marienhaus Klinikum Mainz
        • Contact:
          • Bärbel Kasesberger
        • Contact:
          • Silvio Kittlaß
        • Principal Investigator:
          • Sabine Genth-Zotz, Prof. Dr.
      • München, Germany
        • Recruiting
        • Detusches Herzzentrum München (DHM)
        • Contact:
          • Renate Bratke
        • Principal Investigator:
          • Michael Joner, Prof. Dr.
        • Sub-Investigator:
          • Tobias Lenz, Dr.
      • München, Germany, 83179
        • Not yet recruiting
        • Internistisches Klinikum München Süd GmbH, Klinik für Kardiologie und internistische Intensivmedizin
        • Contact:
        • Principal Investigator:
          • Lukas Gleirscher, Dr.
      • Neuwied, Germany
        • Not yet recruiting
        • Marienhaus Klinikum Bendorf - Neuwied - Waldbreitbach
        • Contact:
        • Principal Investigator:
          • Burkhard Hügel, Dr.
      • Stuttgart, Germany
        • Recruiting
        • Robert-Bosch-Krankenhaus GmbH Stuttgart
        • Contact:
          • Sarah Fröbel, Dr.
        • Principal Investigator:
          • Steffen Endres, Dr.
      • Villingen-Schwenningen, Germany
        • Recruiting
        • Schwarzwald-Baar Klinikum Villingen-Schwenningen
        • Contact:
          • Oxana Ruff
        • Contact:
          • Mirjam Lehrer
        • Principal Investigator:
          • Sebastian Ewen, PD Dr.
  • Monaco
      • Monaco, Monaco
        • Active, not recruiting
        • Centre Hospitalier Princesse Grace Monaco
  • Netherlands
      • Alkmaar, Netherlands
        • Suspended
        • Noordwest Ziekenhuisgroep
      • Maastricht, Netherlands, 6229
        • Withdrawn
        • Maastricht University Medical Center
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus MC Rotterdam
        • Contact:
          • V. Zeijen
        • Principal Investigator:
          • Jost Daemen, Dr.
  • Spain
      • Barcelona, Spain, 08916
        • Terminated
        • Hospital Universitario German Trias i Pujol
      • Madrid, Spain, 28040
        • Terminated
        • Hospital Clinico Universitario S.Carlos
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Universitätsspital Basel
        • Principal Investigator:
          • Lucas Lauder, Dr.
        • Sub-Investigator:
          • Felix Mahfoud, Prof. Dr.
      • Geneva, Switzerland
        • Recruiting
        • HUG Geneve Switzerland
        • Contact:
          • Laetitia Gallego
        • Contact:
          • Sylviane Bottone
        • Principal Investigator:
          • Juan Iglesias, Dr.
        • Sub-Investigator:
          • Georg Ehret, Dr.
      • Lucerne, Switzerland
        • Recruiting
        • Heart Center Lucerne -Luzerner Kantonsspital
        • Contact:
          • Brigitta Mehmann
        • Sub-Investigator:
          • Stefan Toggweiler, Prof. Dr.
        • Principal Investigator:
          • Renate Schoenberger-Berzins, Dr.
  • United Kingdom
      • Bournemouth, United Kingdom
        • Active, not recruiting
        • Royal Bournemouth Hospital, Bournemoth
      • Canterbury, United Kingdom
        • Active, not recruiting
        • Kent and Canterbury Hospital, Canterbury
      • Cardiff, United Kingdom
        • Active, not recruiting
        • University Hospital Wales, Cardiff
      • Dudley, United Kingdom
        • Active, not recruiting
        • Russells Hall Hospital
      • Glasgow, United Kingdom
        • Active, not recruiting
        • Queen Elizabeth Hospital, Glasgow
      • Hull, United Kingdom
        • Active, not recruiting
        • Castle Hill Hospital Hull
      • London, United Kingdom
        • Active, not recruiting
        • Royal Brompton Hospital
      • London, United Kingdom
        • Active, not recruiting
        • Hammersmith Hospital (Imperial College Healthcare NHS Trust)
      • London, United Kingdom
        • Active, not recruiting
        • St Thomas' hospital
      • London, United Kingdom
        • Active, not recruiting
        • WHRC - Barts Health, London
      • Newcastle, United Kingdom
        • Suspended
        • Freeman Hospital, Newcastle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all-cause mortality
Time Frame: Through 5 Years post-procedure
Rate of mortality attributed to any causality as per site standard practice.
Through 5 Years post-procedure
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
Through 5 Years post-procedure
Significant decline in renal function
Time Frame: Through 5 Years post-procedure
≥50% increase in serum creatinine (mg/dL)
Through 5 Years post-procedure
New renal artery stenosis
Time Frame: Through 5 Years post-procedure
>70% confirmed by CTA/MRA as per site standard practice.
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)
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.
Through 5 Years post-procedure
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.
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
Time Frame: Through 5 Years post-procedure
Rate of renal major vascular complications attributed to any causality as per site standard practice.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
Incidence of acute myocardial infarction
Time Frame: Through 5 Years post-procedure
Incidence of acute myocardial infarction as per site standard practice.
Through 5 Years post-procedure
Incidence of any coronary revascularization
Time Frame: Through 5 Years post-procedure
Rate of any coronary revascularization as per site standard practice.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure
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.
Through 5 Years post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ReCor Medical, Inc.

Investigators

  • Principal Investigator: Sofie Brouwers, Prof., OLV Ziekenhuis Aalst Belgium
  • Principal Investigator: Felix Mahfoud, Prof., Klinik für Kardiologie, Universitäres Herzzentrum Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-0927

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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