Moderato System: A Double-Blind Randomized Trial Ver 1.1

Brief Summary

The purpose of this double blind randomized study is the evaluation of the safety and efficacy of the Moderato System. The Moderato implantable pulse generator is indicated for patients who have hypertension and also require a dual chamber pacemaker in order to reduce their blood pressure. The primary objectives of this study are to provide evidence of safety and clinical efficacy of the anti-hypertensive effects of the Moderato System. This will be accomplished by evaluating changes in blood pressure in an active treatment vs. a control patient population for a period of 6 months. The device will be considered to have a clinical effectiveness with regard to its anti-hypertension functions if there is a statistically significant and clinically meaningful reduction in mean 24-hour ambulatory systolic blood pressure in the treatment group compared to the control group.

Related Devices