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The "Global Paradise System" Registry
Sponsor: ReCor Medical, Inc.
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.
Official title: The "Global Paradise® System" Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2022-01-13
Completion Date
2031-12-31
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (55)
Medical University of Vienna,
Vienna, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria
OLV Ziekenhuis Aalst
Aalst, Belgium
CHU Saint Pierre Brussels
Brussels, Belgium
UCL St Luc
Brussels, Belgium
Clinique CHS MontLégia
Liège, Belgium
CHU Grenoble Alpes - Hôpital Michallon
Grenoble, La Tronche, France
CHU Bordeaux Hôpital St. André
Bordeaux, France
Assistance Publique Hôpitaux de Marseille (AP-HM)
Marseille, France
HEGP (Hôpital Européen Georges Pompidouv) Paris
Paris, France
Centre Hospitalier de Pau
Pau, France
Krankenhaus Maria Hilf Bad Neuenahr-Ahrweiler
Ahrweiler, Germany
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
Charité Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, Germany
Klinikum Coburg GmbH
Coburg, Germany
Universitätsklinikum Köln
Cologne, Germany
Klinikum Lippe GmbH Detmold
Detmold, Germany
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Germany
Städt. Klinikum Dresden (Standort Friedrichstadt)
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Cardiovasculäres Centrum (CVC) Frankfurt
Frankfurt, Germany
Universitätsklinikum Halle (Saale), AöR
Halle, Germany
St. Barbara-Klinik Hamm Heessen
Hamm, Germany
Universitätsklinikum der Ruhr-Universität Bochum, Medizinische Klinik II
Herne, Germany
University Clinic of Saarland - Homburg
Homburg, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Sana Kliniken Lübeck GmbH
Lübeck, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, Germany
Marienhaus Klinikum Mainz
Mainz, Germany
Internistisches Klinikum München Süd GmbH, Klinik für Kardiologie und internistische Intensivmedizin
München, Germany
Detusches Herzzentrum München (DHM)
München, Germany
Marienhaus Klinikum Bendorf - Neuwied - Waldbreitbach
Neuwied, Germany
Robert-Bosch-Krankenhaus GmbH Stuttgart
Stuttgart, Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany
Centre Hospitalier Princesse Grace Monaco
Monaco, Monaco
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Erasmus MC Rotterdam
Rotterdam, Netherlands
Hospital Universitario German Trias i Pujol
Barcelona, Spain
Hospital Clinico Universitario S.Carlos
Madrid, Spain
Universitätsspital Basel
Basel, Switzerland
HUG Geneve Switzerland
Geneva, Switzerland
Heart Center Lucerne -Luzerner Kantonsspital
Lucerne, Switzerland
Royal Bournemouth Hospital, Bournemoth
Bournemouth, United Kingdom
Kent and Canterbury Hospital, Canterbury
Canterbury, United Kingdom
University Hospital Wales, Cardiff
Cardiff, United Kingdom
Russells Hall Hospital
Dudley, United Kingdom
Queen Elizabeth Hospital, Glasgow
Glasgow, United Kingdom
Castle Hill Hospital Hull
Hull, United Kingdom
Hammersmith Hospital (Imperial College Healthcare NHS Trust)
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom
St Thomas' Hospital
London, United Kingdom
WHRC - Barts Health, London
London, United Kingdom
Freeman Hospital, Newcastle
Newcastle, United Kingdom