The "Global Paradise System" Registry
Recruiting now
Conditions studied: Hypertension
In brief
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.
Key facts
- Study ID
- NCT05027685
- Run by
- ReCor Medical, Inc.
- People needed
- 3000
- Starts
- 2022-01-13
- Expected to finish
- 2031-12-31
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (enrolling)
- Herzzentrum Leipzig GmbH — Leipzig, Germany (enrolling)
- HEGP (Hôpital Européen Georges Pompidouv) Paris — Paris, France (enrolling)
- Städt. Klinikum Dresden (Standort Friedrichstadt) — Dresden, Germany (enrolling)
- Universitätsklinikum der Ruhr-Universität Bochum, Medizinische Klinik II — Herne, Germany (enrolling)
- University Clinic of Saarland - Homburg — Homburg, Germany (enrolling)
- Schwarzwald-Baar Klinikum Villingen-Schwenningen — Villingen-Schwenningen, Germany (enrolling)
- Klinikum Wels-Grieskirchen GmbH — Wels, Austria (enrolling)
- Charité Universitätsmedizin Berlin Campus Benjamin Franklin — Berlin, Germany (enrolling)
- Herzzentrum Dresden GmbH Universitätsklinik — Dresden, Germany (enrolling)
- Universitätsklinikum Halle (Saale), AöR — Halle, Germany (enrolling)
- Marienhaus Klinikum Mainz — Mainz, Germany (enrolling)
- Robert-Bosch-Krankenhaus GmbH Stuttgart — Stuttgart, Germany (enrolling)
- Universitätsspital Basel — Basel, Switzerland (enrolling)
- HUG Geneve Switzerland — Geneva, Switzerland (enrolling)
- Heart Center Lucerne -Luzerner Kantonsspital — Lucerne, Switzerland (enrolling)
- Universitätsmedizin der Johannes Gutenberg Universität Mainz — Mainz, Germany (enrolling)
- Sana Kliniken Lübeck GmbH — Lübeck, Germany (enrolling)
- Detusches Herzzentrum München (DHM) — München, Germany (enrolling)
- Universitäts-Herzzentrum Freiburg Bad Krozingen — Bad Krozingen, Germany (enrolling)
- Universitätsklinikum Köln — Cologne, Germany (enrolling)
- Klinikum Lippe GmbH Detmold — Detmold, Germany (enrolling)
- Erasmus MC Rotterdam — Rotterdam, Netherlands (enrolling)
- Universitätsklinikum Erlangen — Erlangen, Germany (enrolling)
- Hospital Clinico Universitario S.Carlos — Madrid, Spain
Full record on ClinicalTrials.gov
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