The "Global Paradise System" Registry (GPS Registry)

July 5, 2023 updated by: ReCor Medical, Inc.

The "Global Paradise® System" Registry

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Aalst, Belgium
        • Not yet recruiting
        • OLV Ziekenhuis Aalst
        • Contact:
          • Kathy De Knijf
        • Contact:
          • Hedwig Batjoens
        • Principal Investigator:
          • Sofie Brouwers, Prof.
      • Brussel, Belgium
        • Not yet recruiting
        • CHU Saint Pierre Brussels
        • Contact:
          • Séverine Pascal
        • Principal Investigator:
          • P. Xaplanteris, Dr.
      • Brussel, Belgium
        • Not yet recruiting
        • UCL St Luc
        • Contact:
          • TBD TBD
        • Principal Investigator:
          • Alecandre Persu, Prof.
  • France
      • Bordeaux, France
        • Not yet recruiting
        • CHU Bordeaux Hôpital St. André
        • Contact:
          • Julie Gaudissard
        • Contact:
          • Florent Maire
        • Principal Investigator:
          • Antoine Cremer, Dr.
        • Sub-Investigator:
          • Julien Doublet, Dr.
        • Sub-Investigator:
          • Romain Boulestreau, Dr.
      • Paris, France
        • Active, not recruiting
        • HEGP (Hôpital Européen Georges Pompidouv) Paris
      • Pau, France
        • Not yet recruiting
        • Centre Hospitalier De Pau
        • Contact:
          • TBD TBD
        • Principal Investigator:
          • Nicolas Delarche, Dr.
        • Sub-Investigator:
          • Maria Rougier, Dr.
  • Germany
      • Bad Krozingen, Germany
        • Recruiting
        • Universitäts-Herzzentrum Freiburg Bad Krozingen
        • Contact:
          • Olga Greb
        • Contact:
          • Jochen Strübin
        • Principal Investigator:
          • Elias Noory, Dr.
        • Sub-Investigator:
          • Thomas Zeller, Prof. Dr.
      • Berlin, Germany
        • Not yet recruiting
        • Charite Universitatsmedizin Berlin Campus Benjamin Franklin
        • Contact:
          • TBD TBD
        • Principal Investigator:
          • David Sinning, Dr.
      • Coburg, Germany
        • Not yet recruiting
        • Klinikum Coburg GmbH
        • Contact:
          • Ute Göbel
        • Contact:
          • Andrea Linß
        • Principal Investigator:
          • Steffen Schnupp, Dr.
        • Sub-Investigator:
          • Christian Mahnkopf, Dr.
      • Detmold, Germany
        • Not yet recruiting
        • Klinikum Lippe GmbH Detmold
        • Contact:
          • Angelika Göckeler
        • Contact:
          • Marion Denart
        • Principal Investigator:
          • Dirk-Udo Härtel, Dr.
      • Dresden, Germany
        • Not yet recruiting
        • Herzzentrum Dresden GmbH Universitätsklinik
        • Contact:
          • Monika Famulla
        • Principal Investigator:
          • Robert Höllriegel, Dr.
      • Düsseldorf, Germany
        • Not yet recruiting
        • Universitatsklinikum Dusseldorf
        • Contact:
          • Claudia Schmid, Dr.
        • Principal Investigator:
          • Johannes Stegbauer, Prof. Dr.
      • Erlangen, Germany
        • Active, not recruiting
        • Universitätsklinikum Erlangen
      • Frankfurt, Germany
        • Active, not recruiting
        • CardioVasculares Centrum (CVC) Frankfurt
      • Hamm, Germany
        • Active, not recruiting
        • St. Barbara-Klinik Hamm Heessen
      • Homburg, Germany, D-66421
        • Recruiting
        • University Clinic of Saarland - Homburg
        • Contact:
          • Christina Koch
        • Principal Investigator:
          • Felix Mahfoud, Prof. Dr.
      • Köln, Germany
        • Not yet recruiting
        • Universitatsklinikum Koln
        • Contact:
          • Ana Heinrichs
        • Principal Investigator:
          • Marcel Halbach, Prof. Dr.
      • Leipzig, Germany, D-04289
        • Recruiting
        • Herzzentrum Leipzig GmbH
        • Contact:
          • Ina Wagner
        • Principal Investigator:
          • Karl Fengler, Dr.
        • Sub-Investigator:
          • Philipp Lurz, Prof.
      • Lübeck, Germany
        • Recruiting
        • Sana Kliniken Lübeck gGmbH
        • Contact:
          • Tanja Köllner
        • Contact:
          • Luise Blödorn
        • Principal Investigator:
          • Joachim Weil, Prof.
      • Mainz, Germany
        • Recruiting
        • Marienhaus Klinikum Mainz
        • Contact:
          • Bärbel Kasesberger
        • Contact:
          • Silvio Kittlaß
        • Principal Investigator:
          • Sabine Genth-Zotz, Prof. Dr.
      • München, Germany
        • Recruiting
        • Detusches Herzzentrum München (DHM)
        • Contact:
          • Renate Bratke
        • Principal Investigator:
          • Michael Joner, Prof. Dr.
        • Sub-Investigator:
          • Tobias Lenz, Dr.
      • Stuttgart, Germany
        • Not yet recruiting
        • Robert-Bosch-Krankenhaus GmbH Stuttgart
        • Contact:
          • Sarah Fröbel, Dr.
        • Principal Investigator:
          • Steffen Endres, Dr.
      • Villingen-Schwenningen, Germany
        • Not yet recruiting
        • Schwarzwald-Baar Klinikum Villingen-Schwenningen
        • Contact:
          • Oxana Ruff
        • Contact:
          • Mirjam Lehrer
        • Principal Investigator:
          • Werner Jung, Prof. Dr.
  • Monaco
      • Monaco, Monaco
        • Not yet recruiting
        • Centre Hospitalier Princesse Grace Monaco
        • Contact:
          • Céline Dugourd
        • Principal Investigator:
          • Atul Pathak, Prof.
  • Netherlands
      • Alkmaar, Netherlands
        • Not yet recruiting
        • Noordwest Ziekenhuisgroep
        • Contact:
          • Hanneke Bakker
        • Sub-Investigator:
          • Jan van Ramshorst, Dr.
        • Sub-Investigator:
          • Dedic Admir, Dr.
      • Rotterdam, Netherlands
        • Not yet recruiting
        • Erasmus MC Rotterdam
        • Contact:
          • V. Zeijen
        • Principal Investigator:
          • Jost Daemen, Dr.
  • Switzerland
      • Geneva, Switzerland
        • Recruiting
        • HUG Geneve Switzerland
        • Contact:
          • Laetitia Gallego
        • Contact:
          • Sylviane Bottone
        • Principal Investigator:
          • Juan Iglesias, Dr.
        • Sub-Investigator:
          • Georg Ehret, Dr.
      • Luzern, Switzerland
        • Not yet recruiting
        • Heart Center Lucerne -Luzerner Kantonsspital
        • Contact:
          • Brigitta Mehmann
        • Principal Investigator:
          • Stefan Toggweiler, Prof. Dr.
        • Sub-Investigator:
          • Renate Schoenberger-Berzins, Dr.
  • United Kingdom
      • Bournemouth, United Kingdom
        • Not yet recruiting
        • Royal Bournemouth Hospital, Bournemoth
        • Contact:
          • Stephanie Horler
        • Contact:
          • Sharon Cassidy
        • Principal Investigator:
          • Terry Levy, Dr.
      • Canterbury, United Kingdom
        • Not yet recruiting
        • Kent and Canterbury Hospital, Canterbury
        • Contact:
          • Gemma Hector
        • Principal Investigator:
          • Tim Doulton, Dr.
        • Sub-Investigator:
          • Neelanjan Das, Dr.
      • Cardiff, United Kingdom
        • Not yet recruiting
        • University Hospital Wales, Cardiff
        • Contact:
          • Elizabeth Thompson
        • Principal Investigator:
          • Andrew Sharp, Prof.
      • Glasgow, United Kingdom
        • Not yet recruiting
        • Queen Elizabeth Hospital, Glasgow
        • Contact:
          • Ammani Brown
        • Contact:
          • Lesley Gilmour
        • Principal Investigator:
          • Linsay MyCallum
      • London, United Kingdom
        • Not yet recruiting
        • Hammersmith Hospital (Imperial College Healthcare NHS Trust)
        • Contact:
          • Maricris Tuason
        • Contact:
          • Nelisa Poshai
        • Principal Investigator:
          • Sayan Sen, Dr.
      • London, United Kingdom
        • Not yet recruiting
        • WHRC - Barts Health, London
        • Contact:
          • Armida Balawon
        • Principal Investigator:
          • Manish Saxena, Dr.
      • Newcastle, United Kingdom
        • Not yet recruiting
        • Freeman Hospital, Newcastle
        • Contact:
          • Victoria Bridgett
        • Contact:
          • Lynn D Langhorne
        • Principal Investigator:
          • Tim Ellam, Dr.
        • Sub-Investigator:
          • Alan Bagnall, Dr.
        • Sub-Investigator:
          • Ralph Jackson, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The GPS Registry will collect both retrospective and prospective data in patients treated as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Renal Denervation Treatment
Patients candidate for treatment or already treated within 6 months prior to consent, as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System, will be enrolled in this single arm registry.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all-cause mortality
Time Frame: Through 5 Years post-procedure
Rate of mortality attributed to any causality as per site standard practice.
Through 5 Years post-procedure
Incidence of new onset end-stage renal disease
Time Frame: Through 5 Years post-procedure
eGFR<15 mL/min/m2 or need for renal replacement therapy as per site standard practice
Through 5 Years post-procedure
Significant decline in renal function
Time Frame: Through 5 Years post-procedure
≥50% increase in serum creatinine (mg/dL)
Through 5 Years post-procedure
New renal artery stenosis
Time Frame: Through 5 Years post-procedure
>70% confirmed by CTA/MRA as per site standard practice.
Through 5 Years post-procedure
Incidence of renal artery perforation or dissection requiring an invasive intervention
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Incidence of major vascular complications (e.g, clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion as per site standard practice
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Incidence of hospitalization for hypertensive crisis or symptomatic hypotension
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF)
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Incidence of new onset stroke, TIA or CVA
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Incidence of acute myocardial infarction
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Incidence of any coronary revascularization
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Percentage of subjects who are controlled according to current guidelines
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Change in office/home/ambulatory pulse pressure in mmHg
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Change in office/home/ambulatory heart rate in bpm
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Analysis of quarterly Home BP in mmHg
Time Frame: Through 5 Years post-procedure
Through 5 Years post-procedure
Change from enrollment in quality of life scores as measured by the 12-item Short Form Health Survey (SF-12)
Time Frame: Through 5 Years post-procedure
The 12-item Short Form Health Survey (SF-12) is a measure of health-related quality-of-life. Scores for each domain range from 0 to 100, with a higher score indicating a more favorable health state.
Through 5 Years post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ReCor Medical, Inc.

Investigators

  • Principal Investigator: Melvin Lobo, Prof., Barts NIHR Biomedical Research Centre, William Harvey Research Institute, QMUL
  • Principal Investigator: Felix Mahfoud, Prof., UKS Universitätsklinikum des Saarlandes, Kardiologie, Angiologie und internistische Intensivmedizin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-0927

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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