Kota

Researchers are evaluating the Symplicity Spyral system for renal denervation to see if treating the main and first order branch renal arteries can shorten the procedure time and reduce blood pressure as effectively as previous methods. This study focuses on adults with uncontrolled hypertension and compares this streamlined approach to prior procedural techniques used in related clinical trials. The trial is part of the larger SPYRAL AFFIRM protocol conducted in the EU and APAC regions, aiming to assess long-term safety, effectiveness, and durability of the treatment. Participants undergo a renal angiography followed by the renal denervation procedure using the Symplicity Spyral multi-electrode renal denervation system. The treatment targets only the main and first order branch renal arteries, differing from earlier studies that treated all accessible renal arterial vessels between 3 and 8 mm in diameter, including accessory and branch arteries. This streamlined approach is expected to reduce the procedure time while maintaining blood pressure control. During the study, participants' blood pressure is carefully monitored at baseline and over six months following treatment. Evaluations include office systolic and diastolic blood pressure, home blood pressure measurements, and 24-hour ambulatory blood pressure monitoring. Researchers also track procedure time and assess safety and durability outcomes. The study focuses on individuals diagnosed with hypertension and elevated blood pressure levels to determine the effectiveness of this new treatment method.