The "Global Paradise System" Registry

Last updated: June 2, 2026
Sponsor: ReCor Medical, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Stress

Vascular Diseases

Treatment

The Paradise Ultrasound Renal Denervation System

Clinical Study ID

NCT05027685
CLN-0927
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Appropriately signed and dated informed consent

  • Age ≥18 at time of consent

  • Patient candidate for renal denervation with the Paradise System based onphysician's assessment OR Patient treated with the Paradise Ultrasound RenalDenervation System within the 6 months prior to consent

Exclusion

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 Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: The Paradise Ultrasound Renal Denervation System
Phase:
Study Start date:
January 13, 2022
Estimated Completion Date:
December 31, 2031

Study 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

Connect with a study center

  • Medical University of Vienna,

    Vienna, 1090
    Austria

    Suspended

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600
    Austria

    Active - Recruiting

  • OLV Ziekenhuis Aalst

    Aalst,
    Belgium

    Site Not Available

  • UCL St Luc

    Brussel,
    Belgium

    Site Not Available

  • CHU Saint Pierre Brussels

    Brussels,
    Belgium

    Site Not Available

  • UCL St Luc

    Brussels,
    Belgium

    Site Not Available

  • Clinique CHS MontLégia

    Liège, 4000
    Belgium

    Site Not Available

  • CHU Grenoble Alpes - Hôpital Michallon

    Grenoble, La Tronche 38700
    France

    Site Not Available

  • CHU Bordeaux Hôpital St. André

    Bordeaux,
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille (AP-HM)

    Marseille, 13354
    France

    Site Not Available

  • HEGP (Hôpital Européen Georges Pompidouv) Paris

    Paris,
    France

    Active - Recruiting

  • Centre Hospitalier de Pau

    Pau,
    France

    Site Not Available

  • Krankenhaus Maria Hilf Bad Neuenahr-Ahrweiler

    Ahrweiler, 53474
    Germany

    Suspended

  • Universitäts-Herzzentrum Freiburg Bad Krozingen

    Bad Krozingen,
    Germany

    Active - Recruiting

  • Charité Universitätsmedizin Berlin Campus Benjamin Franklin

    Berlin,
    Germany

    Active - Recruiting

  • Klinikum Coburg GmbH

    Coburg,
    Germany

    Terminated

  • Universitätsklinikum Köln

    Cologne,
    Germany

    Active - Recruiting

  • Klinikum Lippe GmbH Detmold

    Detmold,
    Germany

    Active - Recruiting

  • Herzzentrum Dresden GmbH Universitätsklinik

    Dresden,
    Germany

    Active - Recruiting

  • Städt. Klinikum Dresden (Standort Friedrichstadt)

    Dresden,
    Germany

    Active - Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf,
    Germany

    Active - Recruiting

  • Universitätsklinikum Erlangen

    Erlangen,
    Germany

    Active - Recruiting

  • Cardiovasculäres Centrum (CVC) Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • Universitätsklinikum Halle (Saale), AöR

    Halle, 06120
    Germany

    Active - Recruiting

  • St. Barbara-Klinik Hamm Heessen

    Hamm,
    Germany

    Site Not Available

  • Universitätsklinikum der Ruhr-Universität Bochum, Medizinische Klinik II

    Herne, 44625
    Germany

    Active - Recruiting

  • University Clinic of Saarland - Homburg

    Homburg, D-66421
    Germany

    Active - Recruiting

  • Herzzentrum Leipzig GmbH

    Leipzig, D-04289
    Germany

    Active - Recruiting

  • Sana Kliniken Lübeck GmbH

    Lübeck,
    Germany

    Active - Recruiting

  • Sana Kliniken Lübeck gGmbH

    Lübeck,
    Germany

    Active - Recruiting

  • Marienhaus Klinikum Mainz

    Mainz,
    Germany

    Active - Recruiting

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

  • Detusches Herzzentrum München (DHM)

    München,
    Germany

    Active - Recruiting

  • Internistisches Klinikum München Süd GmbH, Klinik für Kardiologie und internistische Intensivmedizin

    München, 83179
    Germany

    Site Not Available

  • Marienhaus Klinikum Bendorf - Neuwied - Waldbreitbach

    Neuwied,
    Germany

    Site Not Available

  • Robert-Bosch-Krankenhaus GmbH Stuttgart

    Stuttgart,
    Germany

    Active - Recruiting

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen

    Villingen-Schwenningen,
    Germany

    Active - Recruiting

  • Centre Hospitalier Princesse Grace Monaco

    Monaco,
    Monaco

    Site Not Available

  • Noordwest Ziekenhuisgroep

    Alkmaar,
    Netherlands

    Suspended

  • Maastricht University Medical Center

    Maastricht, 6229
    Netherlands

    Site Not Available

  • Erasmus MC Rotterdam

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Hospital Universitario German Trias i Pujol

    Barcelona, 08916
    Spain

    Terminated

  • Hospital Clinico Universitario S.Carlos

    Madrid, 28040
    Spain

    Terminated

  • Universitätsspital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • HUG Geneve Switzerland

    Geneva,
    Switzerland

    Active - Recruiting

  • Heart Center Lucerne -Luzerner Kantonsspital

    Lucerne,
    Switzerland

    Active - Recruiting

  • Royal Bournemouth Hospital, Bournemoth

    Bournemouth,
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital, Canterbury

    Canterbury,
    United Kingdom

    Site Not Available

  • University Hospital Wales, Cardiff

    Cardiff,
    United Kingdom

    Site Not Available

  • Russells Hall Hospital

    Dudley,
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital, Glasgow

    Glasgow,
    United Kingdom

    Site Not Available

  • Castle Hill Hospital Hull

    Hull,
    United Kingdom

    Site Not Available

  • Hammersmith Hospital (Imperial College Healthcare NHS Trust)

    London,
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London,
    United Kingdom

    Site Not Available

  • St Thomas' Hospital

    London,
    United Kingdom

    Site Not Available

  • WHRC - Barts Health, London

    London,
    United Kingdom

    Site Not Available

  • Freeman Hospital, Newcastle

    Newcastle,
    United Kingdom

    Suspended

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