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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
2023-07-07
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 (35)
OLV Ziekenhuis Aalst
Aalst, Belgium
CHU Saint Pierre Brussels
Brussels, Belgium
UCL St Luc
Brussels, Belgium
CHU Bordeaux Hôpital St. André
Bordeaux, France
HEGP (Hôpital Européen Georges Pompidouv) Paris
Paris, France
Centre Hospitalier de Pau
Pau, France
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
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Cardiovasculäres Centrum (CVC) Frankfurt
Frankfurt, Germany
St. Barbara-Klinik Hamm Heessen
Hamm, Germany
University Clinic of Saarland - Homburg
Homburg, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Sana Kliniken Lübeck gGmbH
Lübeck, Germany
Marienhaus Klinikum Mainz
Mainz, Germany
Detusches Herzzentrum München (DHM)
München, 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
Erasmus MC Rotterdam
Rotterdam, Netherlands
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
Queen Elizabeth Hospital, Glasgow
Glasgow, United Kingdom
Hammersmith Hospital (Imperial College Healthcare NHS Trust)
London, United Kingdom
WHRC - Barts Health, London
London, United Kingdom
Freeman Hospital, Newcastle
Newcastle, United Kingdom