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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 - Hopital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ReCor Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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