The "Global Paradise System" Registry
- Conditions
- Hypertension
- Interventions
- Device: The Paradise Ultrasound Renal Denervation System
- Registration Number
- NCT05027685
- Lead Sponsor
- ReCor Medical, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Renal Denervation Treatment The Paradise Ultrasound Renal Denervation System 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.
- Primary Outcome Measures
Name Time Method Incidence of all-cause mortality Through 5 Years post-procedure Rate of mortality attributed to any causality as per site standard practice.
Incidence of hospitalization for hypertensive crisis or symptomatic hypotension Through 5 Years post-procedure Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF) Through 5 Years post-procedure Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment Through 5 Years post-procedure Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg Through 5 Years post-procedure Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg Through 5 Years post-procedure New renal artery stenosis Through 5 Years post-procedure \>70% confirmed by CTA/MRA as per site standard practice.
Incidence of renal artery perforation or dissection requiring an invasive intervention Through 5 Years post-procedure Incidence of new onset stroke, TIA or CVA Through 5 Years post-procedure Incidence of acute myocardial infarction Through 5 Years post-procedure Change in office/home/ambulatory pulse pressure in mmHg Through 5 Years post-procedure Analysis of quarterly Home BP in mmHg Through 5 Years post-procedure Incidence of new onset end-stage renal disease Through 5 Years post-procedure eGFR\<15 mL/min/m2 or need for renal replacement therapy as per site standard practice
Significant decline in renal function Through 5 Years post-procedure ≥50% increase in serum creatinine (mg/dL)
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 Through 5 Years post-procedure Incidence of any coronary revascularization Through 5 Years post-procedure Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment Through 5 Years post-procedure Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment Through 5 Years post-procedure Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg Through 5 Years post-procedure Change in office/home/ambulatory heart rate in bpm Through 5 Years post-procedure Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications Through 5 Years post-procedure Percentage of subjects who are controlled according to current guidelines 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) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
OLV Ziekenhuis Aalst
🇧🇪Aalst, Belgium
CHU Saint Pierre Brussels
🇧🇪Brussel, Belgium
HEGP (Hôpital Européen Georges Pompidouv) Paris
🇫🇷Paris, France
UCL St Luc
🇧🇪Brussel, Belgium
CHU Bordeaux Hôpital St. André
🇫🇷Bordeaux, France
Centre Hospitalier de Pau
🇫🇷Pau, France
Universitäts-Herzzentrum Freiburg Bad Krozingen
🇩🇪Bad Krozingen, Germany
Charité Universitätsmedizin Berlin Campus Benjamin Franklin
🇩🇪Berlin, Germany
Klinikum Coburg GmbH
🇩🇪Coburg, Germany
Klinikum Lippe GmbH Detmold
🇩🇪Detmold, Germany
Herzzentrum Dresden GmbH Universitätsklinik
🇩🇪Dresden, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
St. Barbara-Klinik Hamm Heessen
🇩🇪Hamm, Germany
University Clinic of Saarland - Homburg
🇩🇪Homburg, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Cardiovasculäres Centrum (CVC) Frankfurt
🇩🇪Frankfurt, Germany
Universitätsklinikum Köln
🇩🇪Köln, Germany
Sana Kliniken Lübeck gGmbH
🇩🇪Lübeck, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Marienhaus Klinikum Mainz
🇩🇪Mainz, Germany
Robert-Bosch-Krankenhaus GmbH Stuttgart
🇩🇪Stuttgart, Germany
Detusches Herzzentrum München (DHM)
🇩🇪München, Germany
HUG Geneve Switzerland
🇨🇭Geneva, Switzerland
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands
Schwarzwald-Baar Klinikum Villingen-Schwenningen
🇩🇪Villingen-Schwenningen, Germany
Centre Hospitalier Princesse Grace Monaco
🇲🇨Monaco, Monaco
Erasmus MC Rotterdam
🇳🇱Rotterdam, Netherlands
Heart Center Lucerne -Luzerner Kantonsspital
🇨🇭Luzern, Switzerland
Royal Bournemouth Hospital, Bournemoth
🇬🇧Bournemouth, United Kingdom
Kent and Canterbury Hospital, Canterbury
🇬🇧Canterbury, United Kingdom
University Hospital Wales, Cardiff
🇬🇧Cardiff, United Kingdom
Queen Elizabeth Hospital, Glasgow
🇬🇧Glasgow, United Kingdom
Hammersmith Hospital (Imperial College Healthcare NHS Trust)
🇬🇧London, United Kingdom
WHRC - Barts Health, London
🇬🇧London, United Kingdom
Freeman Hospital, Newcastle
🇬🇧Newcastle, United Kingdom