Adults With Uncontrolled Hypertension Clinical Trial
Official title:
A Prospective, Multi-center, Non-randomized, Controlled Trial in India to Evaluate Efficacy and Safety of Renal Denervation in the Treatment of Uncontrolled Hypertension
This study is to evaluate efficacy and safety of renal denervation in the treatment of uncontrolled hypertension. This study will enroll a minimum of 40 and a maximum of 45 subjects. The study will be conducted at up to 8 actively enrolling investigational sites. The primary endpoint is change in Office Systolic Blood Pressure from baseline to 6 months post-procedure.
Estimated enrollment Start: May 2013 (estimated 90 day duration) Estimated last follow-up: September 2013 Follow-Up Duration: Subjects in the intent-to-treat population will be followed from enrollment through 6 months ±14 days for the effectiveness and safety endpoints ;