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.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of all-cause mortality
Timeframe: Through 5 Years post-procedure
Incidence of new onset end-stage renal disease
Timeframe: Through 5 Years post-procedure
Significant decline in renal function
Timeframe: Through 5 Years post-procedure
New renal artery stenosis
Timeframe: Through 5 Years post-procedure
Incidence of renal artery perforation or dissection requiring an invasive intervention
Timeframe: 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
Timeframe: Through 5 Years post-procedure
Incidence of hospitalization for hypertensive crisis or symptomatic hypotension
Timeframe: Through 5 Years post-procedure
Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF)
Timeframe: Through 5 Years post-procedure
Incidence of new onset stroke, TIA or CVA
Timeframe: Through 5 Years post-procedure
Incidence of acute myocardial infarction
Timeframe: Through 5 Years post-procedure
Incidence of any coronary revascularization
Timeframe: Through 5 Years post-procedure
Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment
Timeframe: Through 5 Years post-procedure
Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment
Timeframe: Through 5 Years post-procedure
Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment
Timeframe: Through 5 Years post-procedure
Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Timeframe: Through 5 Years post-procedure
Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Timeframe: Through 5 Years post-procedure
Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Timeframe: Through 5 Years post-procedure
Percentage of subjects who are controlled according to current guidelines
Timeframe: Through 5 Years post-procedure
Change in office/home/ambulatory pulse pressure in mmHg
Timeframe: Through 5 Years post-procedure
Change in office/home/ambulatory heart rate in bpm
Timeframe: Through 5 Years post-procedure
Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications
Timeframe: Through 5 Years post-procedure
Analysis of quarterly Home BP in mmHg
Timeframe: 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)
Timeframe: Through 5 Years post-procedure