Study Comparing the TIVUS Renal Denervation System to a Sham Procedure for Treating Hypertension in Adults Aged 22 to 75

What this Trial Is About

The trial investigates the adjunctive effectiveness and safety of the TIVUS Renal Denervation System in adults with hypertension. It focuses on subjects with uncontrolled hypertension taking up to two different anti-hypertensive drugs who will stop these medications during the study, as well as subjects with controlled hypertension taking one to two anti-hypertensive drugs who also agree to a medication wash-out period. This international, multicenter, randomized, double-blind, sham-controlled study aims to evaluate blood pressure reduction and safety outcomes in these groups. Participants will undergo a 4-week medication wash-out period before receiving either the TIVUS Renal Denervation procedure or a sham angiogram procedure. After the procedure, subjects remain off anti-hypertensive medications for two months. Subjects with uncontrolled hypertension restart medications following a specific escalation protocol two months after the procedure. The sham procedure is minimally invasive, and unblinding occurs six months post-procedure, with crossover to the TIVUS treatment allowed for uncontrolled sham subjects. Those treated with TIVUS will be followed up to 36 months. Throughout the study, participants will have their blood pressure monitored using daytime ambulatory systolic blood pressure measurements and other blood pressure assessments. Researchers will also track major adverse events within 30 days and six months after the procedure. Participants will undergo renal imaging to confirm eligibility and will have follow-up visits for up to three years. The study carefully monitors safety, medication adherence, and blood pressure changes to evaluate the TIVUS systems performance.

THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension