The "Global Paradise System" Registry

Official title

The "Global Paradise® System" Registry

Overview

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.

Detailed description

Renal denervation (RDN) by way of ultrasound is is a catheter-based technique to deliver ultrasound energy to thermally ablate and disrupt the renal efferent and afferent sympathetic nerves while sparing the renal arterial wall. The ReCor Medical ParadiseTM Ultrasound Renal Denervation System (ParadiseTM System) is a product admitted for clinical use implementing this technique. The goal of ultrasound renal denervation (ultrasound RDN) is to achieve a reduction in sympathetic over-activity with the resultant effect of reducing systemic arterial blood pressure (BP), and mitigating resultant end organ damage. With the expected increase in the number of patients to be treated in clinical practice with ultrasound RDN, and the importance of collecting real-world data on the long-term use and performance of ultrasound RDN through the use of the ParadiseTM System in a large population of patients, the Global ParadiseTM System (GPS) Registry has been set-up

Interventions

• 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.

Primary outcome measures

• Incidence of all-cause mortality [Time frame: Through 5 Years post-procedure]
• Incidence of new onset end-stage renal disease [Time frame: Through 5 Years post-procedure]
• Significant decline in renal function [Time frame: Through 5 Years post-procedure]
• New renal artery stenosis [Time frame: Through 5 Years post-procedure]
• Incidence of renal artery perforation or dissection requiring an invasive intervention [Time frame: 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]
• Incidence of hospitalization for hypertensive crisis or symptomatic hypotension [Time frame: 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]
• Incidence of new onset stroke, TIA or CVA [Time frame: Through 5 Years post-procedure]
• Incidence of acute myocardial infarction [Time frame: Through 5 Years post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Germany · 24 centers

• Krankenhaus Maria Hilf Bad Neuenahr-Ahrweiler — Ahrweiler
• Universitäts-Herzzentrum Freiburg Bad Krozingen — Bad Krozingen
• Charité Universitätsmedizin Berlin Campus Benjamin Franklin — Berlin
• Klinikum Coburg GmbH — Coburg
• Universitätsklinikum Köln — Cologne
• Klinikum Lippe GmbH Detmold — Detmold
• Herzzentrum Dresden GmbH Universitätsklinik — Dresden
• Städt. Klinikum Dresden (Standort Friedrichstadt) — Dresden
• … and 16 more centers

United Kingdom · 11 centers

• Royal Bournemouth Hospital, Bournemoth — Bournemouth
• Kent and Canterbury Hospital, Canterbury — Canterbury
• University Hospital Wales, Cardiff — Cardiff
• Russells Hall Hospital — Dudley
• Queen Elizabeth Hospital, Glasgow — Glasgow
• Castle Hill Hospital Hull — Hull
• Hammersmith Hospital (Imperial College Healthcare NHS Trust) — London
• Royal Brompton Hospital — London
• … and 3 more centers

France · 5 centers

• CHU Grenoble Alpes - Hôpital Michallon — Grenoble
• CHU Bordeaux Hôpital St. André — Bordeaux
• Assistance Publique Hôpitaux de Marseille (AP-HM) — Marseille
• HEGP (Hôpital Européen Georges Pompidouv) Paris — Paris
• Centre Hospitalier de Pau — Pau

Belgium · 4 centers

• OLV Ziekenhuis Aalst — Aalst
• CHU Saint Pierre Brussels — Brussels
• UCL St Luc — Brussels
• Clinique CHS MontLégia — Liège

Netherlands · 3 centers

• Noordwest Ziekenhuisgroep — Alkmaar
• Maastricht University Medical Center — Maastricht
• Erasmus MC Rotterdam — Rotterdam

Switzerland · 3 centers

• Universitätsspital Basel — Basel
• HUG Geneve Switzerland — Geneva
• Heart Center Lucerne -Luzerner Kantonsspital — Lucerne

Austria · 2 centers

• Medical University of Vienna, — Vienna
• Klinikum Wels-Grieskirchen GmbH — Wels

Spain · 2 centers

• Hospital Universitario German Trias i Pujol — Barcelona
• Hospital Clinico Universitario S.Carlos — Madrid

Monaco · 1 center

• Centre Hospitalier Princesse Grace Monaco — Monaco

Identifiers

NCT: NCT05027685 · CLN-0927

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗