The "Global Paradise System" Registry
Recruiting · NCT05027685 · Observational (researchers observe without assigning treatment) · Lead sponsor: ReCor Medical, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
The Paradise Ultrasound Renal Denervation System
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
55 locations listed.
- OLV Ziekenhuis Aalst - Aalst, Belgium
- Krankenhaus Maria Hilf Bad Neuenahr-Ahrweiler - Ahrweiler, Germany
- Noordwest Ziekenhuisgroep - Alkmaar, Netherlands
- Universitäts-Herzzentrum Freiburg Bad Krozingen - Bad Krozingen, Germany
- Hospital Universitario German Trias i Pujol - Barcelona, Spain
- Universitätsspital Basel - Basel, Switzerland
- Charité Universitätsmedizin Berlin Campus Benjamin Franklin - Berlin, Germany
- CHU Bordeaux Hôpital St. André - Bordeaux, France
- Royal Bournemouth Hospital, Bournemoth - Bournemouth, United Kingdom
- CHU Saint Pierre Brussels - Brussels, Belgium
- UCL St Luc - Brussels, Belgium
- Kent and Canterbury Hospital, Canterbury - Canterbury, United Kingdom
- University Hospital Wales, Cardiff - Cardiff, United Kingdom
- 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
- Russells Hall Hospital - Dudley, United Kingdom
- Universitätsklinikum Düsseldorf - Düsseldorf, Germany
- Universitätsklinikum Erlangen - Erlangen, Germany
- Cardiovasculäres Centrum (CVC) Frankfurt - Frankfurt, Germany
- HUG Geneve Switzerland - Geneva, Switzerland
- Queen Elizabeth Hospital, Glasgow - Glasgow, United Kingdom
- 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
- Castle Hill Hospital Hull - Hull, United Kingdom
- Herzzentrum Leipzig GmbH - Leipzig, Germany
- Clinique CHS MontLégia - Liège, Belgium
- 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
- Heart Center Lucerne -Luzerner Kantonsspital - Lucerne, Switzerland
- Sana Kliniken Lübeck GmbH - Lübeck, Germany
- Maastricht University Medical Center - Maastricht, Netherlands
- Hospital Clinico Universitario S.Carlos - Madrid, Spain
- Universitätsmedizin der Johannes Gutenberg Universität Mainz - Mainz, Germany
- Marienhaus Klinikum Mainz - Mainz, Germany
- Assistance Publique Hôpitaux de Marseille (AP-HM) - Marseille, France
- Centre Hospitalier Princesse Grace Monaco - Monaco, Monaco
- 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
- Freeman Hospital, Newcastle - Newcastle, United Kingdom
- HEGP (Hôpital Européen Georges Pompidouv) Paris - Paris, France
- Centre Hospitalier de Pau - Pau, France
- Erasmus MC Rotterdam - Rotterdam, Netherlands
- Robert-Bosch-Krankenhaus GmbH Stuttgart - Stuttgart, Germany
- Medical University of Vienna, - Vienna, Austria
- Schwarzwald-Baar Klinikum Villingen-Schwenningen - Villingen-Schwenningen, Germany
- Klinikum Wels-Grieskirchen GmbH - Wels, Austria
- CHU Grenoble Alpes - Hôpital Michallon - Grenoble, La Tronche, France