- The “Global Paradise System” Registry — Recruiting • Cardiology / Cardiovascular • NCT05027685.
- What is being tested: The GPS Registry is observing real-world outcomes in patients receiving standard clinical care, with additional collection of home blood pressure telemetry data and patient-reported outcomes to evaluate treatment effectiveness and patient experience outside controlled settings.
- Patient eligibility overview: This is an observational registry enrolling patients treated according to standard clinical practice across multiple centres; specific inclusion/exclusion criteria are not detailed in the provided summary but would typically reflect the patient population relevant to the intervention being monitored.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.