The "Global Paradise System" Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (55)

+ 15 more sites — see the full list on the official registry below.

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