Global Paradise System Registry for Patients with Hypertension Using the Paradise Ultrasound Renal Denervation Device

What this Trial Is About

This observational registry study is focused on patients with hypertension who are candidates for renal denervation using the Paradise Ultrasound Renal Denervation System. The registry aims to collect real-world data on the long-term safety and performance of this catheter-based ultrasound treatment, which targets renal nerves to reduce blood pressure and prevent organ damage. The study is designed to monitor outcomes over an extended period in routine clinical practice settings. Participants include patients selected for treatment or those treated within six months before enrollment, based on their physicians assessment. The study collects data without altering standard care and records telemetric home blood pressure measurements and patient-reported quality of life outcomes. The Paradise System delivers ultrasound energy to ablate renal nerves while preserving the artery, aiming to reduce sympathetic nerve activity related to hypertension. Throughout the study, participants will have their health status tracked for up to five years after the procedure. Researchers will monitor various safety and efficacy measures, such as mortality, kidney function, cardiovascular events, and blood pressure changes using home, office, and ambulatory measurements. Quality of life will also be assessed regularly with standardized questionnaires. This long-term observation helps to understand the effects and safety of the Paradise System in everyday clinical use.

The "Global Paradise System" Registry