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NCT05027685: GPS Registry

The "Global Paradise System" Registry

Recruiting now Last updated 7 July 2023
What this trial tests

trial testing The Paradise Ultrasound Renal Denervation System in Hypertension in 3,000 participants. Currently enrolling.

Timeline
13 January 2022
Primary endpoint
31 December 2030
31 December 2031

Quick facts

Lead sponsorReCor Medical, Inc.
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment3,000
Start date13 January 2022
Primary completion31 December 2030
Estimated completion31 December 2031
Sites35 locations across France, Netherlands, Belgium, United Kingdom, Germany, Monaco, Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

ReCor Medical, Inc.

Who can join

18 and older, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Advances in pathogenesis and treatment of essential hypertension.
    Ma J, Chen X. · · 2022 · cited 29× · PMID 36312252 · DOI 10.3389/fcvm.2022.1003852
  2. Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design.
    Mahfoud F, Azizi M, Daemen J, Sharp ASP, et al · · 2024 · cited 15× · PMID 37943324 · DOI 10.1007/s00392-023-02325-x
  3. Renal Denervation for Hypertension: The Current Landscape and Future Directions.
    Fulton B, Giri J, Rader F, Cohen DL, et al · · 2024 · cited 2× · PMID 39006469 · DOI 10.17925/hi.2024.18.1.2

Verify or expand the search:

Other recruiting trials for Hypertension

Currently open trials in the same condition.

Other ReCor Medical, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05027685.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing