Observational Study in China Evaluating Long-Term Safety and Effectiveness of the Symplicity Spyral Renal Denervation System in Adults with Resistant Hypertension

What this Trial Is About

Researchers are evaluating the long-term safety, effectiveness, and durability of the Symplicity Spyral Renal Denervation System in people with resistant hypertension or those who cannot tolerate antihypertensive drugs. This observational study will follow about 500 participants in China for up to 36 months after their treatment to better understand real-world outcomes. The study is sponsored by Medtronic Vascular and aims to track blood pressure changes and related effects over time. Participants have undergone treatment with the Symplicity Spyral Renal Denervation System, a medical device designed to help manage resistant hypertension by targeting the nerves in the renal arteries. This study does not involve assigning treatments but observes patients who have already received this procedure. The study will monitor participants at multiple time points 1, 3, 6, 12, 24, and 36 months after their procedure. During the study, participants will have their blood pressure measured in the office, at home, and through 24-hour ambulatory monitoring. Researchers will also track changes in the number and burden of medications taken, as well as the proportion of patients achieving target blood pressure control. Safety events and other health outcomes will be recorded throughout the 36 months of follow-up. Participants will be asked to provide informed consent and voluntarily take part in the observational study, which will continue until December 2031.

Symplicity China Study