The "Global Paradise System" Registry

Last updated: July 5, 2023
Sponsor: ReCor Medical, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Williams Syndrome

Vascular Diseases

Treatment

The Paradise Ultrasound Renal Denervation System

Clinical Study ID

NCT05027685
CLN-0927
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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'sassessment OR Patient treated with the Paradise Ultrasound Renal Denervation Systemwithin the 6 months prior to consent

Exclusion

Exclusion Criteria: Patients who meet any of the contraindications listed in the Instructions for Use will beexcluded. 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

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: The Paradise Ultrasound Renal Denervation System
Phase:
Study Start date:
January 13, 2022
Estimated Completion Date:
December 31, 2031

Connect with a study center

  • OLV Ziekenhuis Aalst

    Aalst,
    Belgium

    Site Not Available

  • CHU Saint Pierre Brussels

    Brussel,
    Belgium

    Site Not Available

  • UCL St Luc

    Brussel,
    Belgium

    Site Not Available

  • CHU Bordeaux Hôpital St. André

    Bordeaux,
    France

    Site Not Available

  • HEGP (Hôpital Européen Georges Pompidouv) Paris

    Paris,
    France

    Site Not Available

  • Centre Hospitalier de Pau

    Pau,
    France

    Site Not Available

  • Universitäts-Herzzentrum Freiburg Bad Krozingen

    Bad Krozingen,
    Germany

    Active - Recruiting

  • Charité Universitätsmedizin Berlin Campus Benjamin Franklin

    Berlin,
    Germany

    Site Not Available

  • Klinikum Coburg GmbH

    Coburg,
    Germany

    Site Not Available

  • Klinikum Lippe GmbH Detmold

    Detmold,
    Germany

    Site Not Available

  • Herzzentrum Dresden GmbH Universitätsklinik

    Dresden,
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf

    Düsseldorf,
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen,
    Germany

    Site Not Available

  • Cardiovasculäres Centrum (CVC) Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • St. Barbara-Klinik Hamm Heessen

    Hamm,
    Germany

    Site Not Available

  • University Clinic of Saarland - Homburg

    Homburg, D-66421
    Germany

    Active - Recruiting

  • Universitätsklinikum Köln

    Köln,
    Germany

    Site Not Available

  • Herzzentrum Leipzig GmbH

    Leipzig, D-04289
    Germany

    Active - Recruiting

  • Sana Kliniken Lübeck gGmbH

    Lübeck,
    Germany

    Active - Recruiting

  • Marienhaus Klinikum Mainz

    Mainz,
    Germany

    Active - Recruiting

  • Detusches Herzzentrum München (DHM)

    München,
    Germany

    Active - Recruiting

  • Robert-Bosch-Krankenhaus GmbH Stuttgart

    Stuttgart,
    Germany

    Site Not Available

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen

    Villingen-Schwenningen,
    Germany

    Site Not Available

  • Centre Hospitalier Princesse Grace Monaco

    Monaco,
    Monaco

    Site Not Available

  • Noordwest Ziekenhuisgroep

    Alkmaar,
    Netherlands

    Site Not Available

  • Erasmus MC Rotterdam

    Rotterdam,
    Netherlands

    Site Not Available

  • HUG Geneve Switzerland

    Geneva,
    Switzerland

    Active - Recruiting

  • Heart Center Lucerne -Luzerner Kantonsspital

    Luzern,
    Switzerland

    Site Not Available

  • Royal Bournemouth Hospital, Bournemoth

    Bournemouth,
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital, Canterbury

    Canterbury,
    United Kingdom

    Site Not Available

  • University Hospital Wales, Cardiff

    Cardiff,
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital, Glasgow

    Glasgow,
    United Kingdom

    Site Not Available

  • Hammersmith Hospital (Imperial College Healthcare NHS Trust)

    London,
    United Kingdom

    Site Not Available

  • WHRC - Barts Health, London

    London,
    United Kingdom

    Site Not Available

  • Freeman Hospital, Newcastle

    Newcastle,
    United Kingdom

    Site Not Available

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