GPS Registry: The "Global Paradise System" Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- 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]
- 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 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]
- Incidence of new onset stroke, TIA or CVA [Through 5 Years post-procedure]
- Incidence of acute myocardial infarction [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 office 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 home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg [Through 5 Years post-procedure]
- Incidence of office 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]
- Percentage of subjects who are controlled according to current guidelines [Through 5 Years post-procedure]
- Change in office/home/ambulatory pulse pressure in 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]
- Analysis of quarterly Home BP in mmHg [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Appropriately signed and dated informed consent
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Age ≥18 at time of consent
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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:
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Stented renal artery
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Less than 18 years of age
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Pregnant
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Known allergy to contrast medium
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Renal arteries diameter < 3 mm and > 8 mm
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Renal artery with Fibromuscular (FMD) disease
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Renal artery aneurysm
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Renal artery stenosis of any origin >30%
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Iliac/femoral artery stenosis precluding insertion of the Paradise catheter
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Clinic of Saarland - Homburg | Homburg | Germany | D-66421 |
Sponsors and Collaborators
- ReCor Medical, Inc.
Investigators
- Principal Investigator: Prof. Melvin Lobo, Barts NIHR Biomedical Research Centre, William Harvey Research Institute, QMUL
- Principal Investigator: Prof. Felix Mahfoud, UKS Universitätsklinikum des Saarlandes, Kardiologie, Angiologie und internistische Intensivmedizin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLN-0927