Safety and Effectiveness of FlashPoint Renal Denervation Using 3D Cardiac Electrophysiological Mapping for Essential Hypertension A Randomized Controlled Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a renal artery radiofrequency ablation system guided by a three-dimensional cardiac electrophysiological mapping system for treating essential hypertension. This prospective, multi-center, randomized controlled trial includes both drug-control and sham-control studies to provide evidence for product registration, marketing, and clinical use. The study involves adults aged 18 to 70 with uncontrolled essential hypertension despite medication. Participants are assigned to different groups one receives percutaneous renal denervation using the FlashPoint radio-frequency ablation system guided by the Columbus 3D mapping system, while another undergoes a sham procedure consisting of renal artery angiography followed by continued antihypertensive medication. Drug-control research includes 65 subjects divided into renal artery ablation with drug treatment and drug treatment only groups. Sham-control research includes 180 subjects randomized 21 to renal artery ablation with drug treatment or sham procedure with drug treatment. Throughout the study, patients will have blood pressure measurements and medication assessments at 1, 2, 3, 4, 5, 6, and 12 months after the procedure. Urine samples will be collected for drug testing to check medication compliance. Researchers will monitor 24-hour ambulatory mean systolic blood pressure reduction and the incidence of major adverse events up to 6 months and 1 month respectively, along with various secondary outcomes related to blood pressure, drug burden, and safety events.

FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension