Hypertension Clinical Trial
Official title:
Wave VI Feasibility Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension
The Wave VI study is a, multicenter, prospective, double-blind, randomized, sham controlled feasibility study of the safety of renal denervation in patients with stage I and II hypertension who have an average office systolic blood pressure between 150 and 180 mmHg and have not been on any antihypertensive medications for at least six months.
The primary objective of this feasibility study is to assess the safety of renal denervation using externally focused therapeutic ultrasound with non-invasive targeting for patients with stage I and II hypertension who are not on any antihypertensive medications. The key secondary objective is to assess the effect of the therapy on changes from baseline in ambulatory systolic BP. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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