Hypertension
Conditions
Keywords
Hypertension, Blood pressure, Renal Denervation
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
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
DEVICEThe 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.
Sponsors
ReCor Medical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all-cause mortality | Through 5 Years post-procedure | Rate of mortality attributed to any causality as per site standard practice. |
| 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) |
| 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 | Rate of renal artery perforation or dissection attributed to any causality as per site standard practice. |
| 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 | Rate of renal major vascular complications attributed to any causality as per site standard practice. |
| Incidence of hospitalization for hypertensive crisis or symptomatic hypotension | Through 5 Years post-procedure | Hospitalization for hypertensive crisis or symptomatic hypotension as per site standard practice. |
| Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF) | Through 5 Years post-procedure | Hospitalization for major cardiovascular- or hemodynamic-related events as per site standard practice. |
| Incidence of new onset stroke, TIA or CVA | Through 5 Years post-procedure | Incidence of new onset stroke, TIA or CVA as per site standard practice. |
| Incidence of acute myocardial infarction | Through 5 Years post-procedure | Incidence of acute myocardial infarction as per site standard practice. |
| Incidence of any coronary revascularization | Through 5 Years post-procedure | Rate of any coronary revascularization as per site standard practice. |
| Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment | Through 5 Years post-procedure | Rate of reduction in average home systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice. |
| Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment | Through 5 Years post-procedure | Rate of reduction in average office systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice. |
| Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment | Through 5 Years post-procedure | 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. |
| Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg | Through 5 Years post-procedure | Rate of incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice. |
| Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg | Through 5 Years post-procedure | Rate of incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice. |
| Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg | Through 5 Years post-procedure | 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. |
| Percentage of subjects who are controlled according to current guidelines | Through 5 Years post-procedure | Percentage of subjects who are controlled according to current guidelines as per site standard practice. |
| Change in office/home/ambulatory pulse pressure in mmHg | Through 5 Years post-procedure | Rate change in office/home/ambulatory pulse pressure in mmHg as per site standard practice. |
| Change in office/home/ambulatory heart rate in bpm | Through 5 Years post-procedure | Change in office/home/ambulatory heart rate in bpm as per site standard practice. |
| Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications | Through 5 Years post-procedure | Rate percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications per site standard practice. |
| Analysis of quarterly Home BP in mmHg | Through 5 Years post-procedure | Analysis of quarterly Home BP in mmHg as per site standard practice. |
| 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. |
Countries
Austria, Belgium, France, Germany, Monaco, Netherlands, Spain, Switzerland, United Kingdom
Contacts
CONTACTHelen Reeve-Stoffer, PhD
CONTACTHajime Arnold
PRINCIPAL_INVESTIGATORSofie Brouwers, Prof.
OLV Ziekenhuis Aalst Belgium
PRINCIPAL_INVESTIGATORFelix Mahfoud, Prof.
Klinik für Kardiologie, Universitäres Herzzentrum Basel, Switzerland
Outcome results
None listed