Streamlined Renal Denervation Using the Symplicity Spyral System for Adults with Uncontrolled Hypertension

What this Trial Is About

This research aims to evaluate the Symplicity Spyral system for renal denervation in adults with uncontrolled hypertension. It focuses on whether performing the procedure in the main and first order branch renal arteries results in a shorter procedure time and maintains similar effectiveness in lowering blood pressure compared to previous approaches targeting more renal vessels. The study is conducted under the SPYRAL AFFIRM protocol in the EU and APAC regions. Participants undergo renal angiography followed by the renal denervation procedure using the Symplicity Spyral multi-electrode system. This streamlined approach targets fewer renal artery sites compared to earlier clinical studies. The study assesses procedure time and blood pressure changes over several months. The study period includes evaluations at baseline and follow-up visits up to 36 months after the procedure to assess long-term safety, efficacy, and durability. During the study, participants will have office and home blood pressure measurements, 24-hour ambulatory blood pressure monitoring, and assessment of kidney function through eGFR. Researchers will monitor blood pressure control, medication changes, health status, and safety events including major adverse events. Follow-up assessments occur at 3, 6, 12, 24, and 36 months post-procedure, with a total study duration lasting several years to evaluate sustained outcomes and safety.

Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension