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Moderato System in Patients With Hypertension
Sponsor: BackBeat Medical Inc
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. In this amended CS-03 protocol Version 3.0, the study will evaluate the safety and efficacy in a randomized, double-blind study following active treatment vs. a control patient population for a period of 3 month for efficacy and 12 months for safety (In comparison to 6 months for patients under protocol CS-03 Ver 1.1, NCT02837445). The device will be considered to have a clinical effectiveness with regard to its anti-hypertension function 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. The primary efficacy endpoint will be evaluated 3 months after randomization. The Primary safety analysis will compare the treatment and the control after 12 months of treatment.
Official title: Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
203
Start Date
2017-08-30
Completion Date
2021-05-13
Last Updated
2026-06-18
Healthy Volunteers
No
Interventions
BackBeat Moderato System
Eligible patients randomized after optimization phase to PHC ON for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
BackBeat Moderato Sytsem
Eligible patients randomized after optimization phase to PHC OFF for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.
Locations (4)
UZ Brussel - Heart Rhythm Management Center
Brussels, Belgium
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania
Samodzielnym Publicznym Centralnym Szpitalem Klinicznym
Warsaw, Poland
Silesian Center for Heart Diseases
Zabrze, Poland