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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Paradise Ultrasound Renal Denervation System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all-cause mortality | 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 | 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 | ≥50% increase in serum creatinine (mg/dL) | Through 5 Years post-procedure |
| New renal artery stenosis | >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 | Rate of renal artery perforation or dissection attributed to any causality as per site standard practice. | 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 | Rate of renal major vascular complications attributed to any causality as per site standard practice. | Through 5 Years post-procedure |
| Incidence of hospitalization for hypertensive crisis or symptomatic hypotension |
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Inclusion Criteria:
Exclusion Criteria:
Patients who meet any of the contraindications listed in the Instructions for Use will be excluded.
The contraindications are:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen Reeve-Stoffer, PhD | Contact | +44 (0) 794 774 8006 | hreeve-stoffer@recormedical.com | |
| Hajime Arnold | Contact | +1 650 912 9023 | HArnold@recormedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Sofie Brouwers, Prof. | OLV Ziekenhuis Aalst Belgium | Principal Investigator |
| Felix Mahfoud, Prof. | Klinik für Kardiologie, Universitäres Herzzentrum Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, | Suspended | Vienna | 1090 | Austria | ||
| Klinikum Wels-Grieskirchen GmbH |
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|
Hospitalization for hypertensive crisis or symptomatic hypotension as per site standard practice.
| Through 5 Years post-procedure |
| Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF) | Hospitalization for major cardiovascular- or hemodynamic-related events as per site standard practice. | Through 5 Years post-procedure |
| Incidence of new onset stroke, TIA or CVA | Incidence of new onset stroke, TIA or CVA as per site standard practice. | Through 5 Years post-procedure |
| Incidence of acute myocardial infarction | Incidence of acute myocardial infarction as per site standard practice. | Through 5 Years post-procedure |
| Incidence of any coronary revascularization | Rate of any coronary revascularization as per site standard practice. | Through 5 Years post-procedure |
| Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment | Rate of reduction in average home systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice. | Through 5 Years post-procedure |
| Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment | Rate of reduction in average office systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice. | Through 5 Years post-procedure |
| Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment | Rate of reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment as per site standard practice. | Through 5 Years post-procedure |
| Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg | Rate of incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice. | Through 5 Years post-procedure |
| Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg | Rate of incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice. | Through 5 Years post-procedure |
| Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg | Rate of incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice. | Through 5 Years post-procedure |
| Percentage of subjects who are controlled according to current guidelines | Percentage of subjects who are controlled according to current guidelines as per site standard practice. | Through 5 Years post-procedure |
| Change in office/home/ambulatory pulse pressure in mmHg | Rate change in office/home/ambulatory pulse pressure in mmHg as per site standard practice. | Through 5 Years post-procedure |
| Change in office/home/ambulatory heart rate in bpm | Change in office/home/ambulatory heart rate in bpm as per site standard practice. | Through 5 Years post-procedure |
| Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications | Rate percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications per site standard practice. | Through 5 Years post-procedure |
| Analysis of quarterly Home BP in mmHg | Analysis of quarterly Home BP in mmHg as per site standard practice. | 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) | 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 |
| Recruiting |
| Wels |
| 4600 |
| Austria |
|
| OLV Ziekenhuis Aalst | Active, not recruiting | Aalst | Belgium |
| CHU Saint Pierre Brussels | Active, not recruiting | Brussels | Belgium |
| UCL St Luc | Active, not recruiting | Brussels | Belgium |
| Clinique CHS MontLégia | Active, not recruiting | Liège | 4000 | Belgium |
| CHU Grenoble Alpes - Hôpital Michallon | Active, not recruiting | Grenoble | La Tronche | 38700 | France |
| CHU Bordeaux Hôpital St. André | Active, not recruiting | Bordeaux | France |
| Assistance Publique Hôpitaux de Marseille (AP-HM) | Withdrawn | Marseille | 13354 | France |
| HEGP (Hôpital Européen Georges Pompidouv) Paris | Recruiting | Paris | France |
|
| Centre Hospitalier de Pau | Active, not recruiting | Pau | France |
| Krankenhaus Maria Hilf Bad Neuenahr-Ahrweiler | Suspended | Ahrweiler | 53474 | Germany |
| Universitäts-Herzzentrum Freiburg Bad Krozingen | Recruiting | Bad Krozingen | Germany |
|
| Charité Universitätsmedizin Berlin Campus Benjamin Franklin | Recruiting | Berlin | Germany |
|
| Klinikum Coburg GmbH | Terminated | Coburg | Germany |
| Universitätsklinikum Köln | Recruiting | Cologne | Germany |
|
| Klinikum Lippe GmbH Detmold | Recruiting | Detmold | Germany |
|
| Herzzentrum Dresden GmbH Universitätsklinik | Recruiting | Dresden | Germany |
|
| Städt. Klinikum Dresden (Standort Friedrichstadt) | Recruiting | Dresden | Germany |
|
| Universitätsklinikum Düsseldorf | Recruiting | Düsseldorf | Germany |
|
| Universitätsklinikum Erlangen | Recruiting | Erlangen | Germany |
|
| Cardiovasculäres Centrum (CVC) Frankfurt | Withdrawn | Frankfurt | Germany |
| Universitätsklinikum Halle (Saale), AöR | Recruiting | Halle | 06120 | Germany |
|
| St. Barbara-Klinik Hamm Heessen | Active, not recruiting | Hamm | Germany |
| Universitätsklinikum der Ruhr-Universität Bochum, Medizinische Klinik II | Recruiting | Herne | 44625 | Germany |
|
| University Clinic of Saarland - Homburg | Recruiting | Homburg | D-66421 | Germany |
|
| Herzzentrum Leipzig GmbH | Recruiting | Leipzig | D-04289 | Germany |
|
| Sana Kliniken Lübeck GmbH | Recruiting | Lübeck | Germany |
|
| Universitätsmedizin der Johannes Gutenberg Universität Mainz | Recruiting | Mainz | 55131 | Germany |
|
| Marienhaus Klinikum Mainz | Recruiting | Mainz | Germany |
|
| Internistisches Klinikum München Süd GmbH, Klinik für Kardiologie und internistische Intensivmedizin | Not yet recruiting | München | 83179 | Germany |
|
| Detusches Herzzentrum München (DHM) | Recruiting | München | Germany |
|
| Marienhaus Klinikum Bendorf - Neuwied - Waldbreitbach | Not yet recruiting | Neuwied | Germany |
|
| Robert-Bosch-Krankenhaus GmbH Stuttgart | Recruiting | Stuttgart | Germany |
|
| Schwarzwald-Baar Klinikum Villingen-Schwenningen | Recruiting | Villingen-Schwenningen | Germany |
|
| Centre Hospitalier Princesse Grace Monaco | Active, not recruiting | Monaco | Monaco |
| Noordwest Ziekenhuisgroep | Suspended | Alkmaar | Netherlands |
| Maastricht University Medical Center | Withdrawn | Maastricht | 6229 | Netherlands |
| Erasmus MC Rotterdam | Recruiting | Rotterdam | Netherlands |
|
| Hospital Universitario German Trias i Pujol | Terminated | Barcelona | 08916 | Spain |
| Hospital Clinico Universitario S.Carlos | Terminated | Madrid | 28040 | Spain |
| Universitätsspital Basel | Recruiting | Basel | 4031 | Switzerland |
|
| HUG Geneve Switzerland | Recruiting | Geneva | Switzerland |
|
| Heart Center Lucerne -Luzerner Kantonsspital | Recruiting | Lucerne | Switzerland |
|
| Royal Bournemouth Hospital, Bournemoth | Active, not recruiting | Bournemouth | United Kingdom |
| Kent and Canterbury Hospital, Canterbury | Active, not recruiting | Canterbury | United Kingdom |
| University Hospital Wales, Cardiff | Active, not recruiting | Cardiff | United Kingdom |
| Russells Hall Hospital | Active, not recruiting | Dudley | United Kingdom |
| Queen Elizabeth Hospital, Glasgow | Active, not recruiting | Glasgow | United Kingdom |
| Castle Hill Hospital Hull | Active, not recruiting | Hull | United Kingdom |
| Hammersmith Hospital (Imperial College Healthcare NHS Trust) | Active, not recruiting | London | United Kingdom |
| Royal Brompton Hospital | Active, not recruiting | London | United Kingdom |
| St Thomas' Hospital | Active, not recruiting | London | United Kingdom |
| WHRC - Barts Health, London | Active, not recruiting | London | United Kingdom |
| Freeman Hospital, Newcastle | Suspended | Newcastle | United Kingdom |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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