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Moderato System: A Double-Blind Randomized Trial Ver 1.1
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. 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.
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
70
Start Date
2016-07-12
Completion Date
2021-05-13
Last Updated
2026-06-18
Healthy Volunteers
No
Interventions
PHC ON
Eligible patients randomized after optimization phase to PHC ON for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
PHC OFF
Eligible patients randomized after optimization phase to PHC OFF for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.
Locations (12)
Krankenhaus der Elisabethinen
Linz, Austria
Medical University Vienna
Vienna, Austria
UZ Brussel - Heart Rhythm Management Center
Brussels, Belgium
Na Homolce Hospital
Prague, Czechia
Semmelweis University Heart and Vascular Center
Budapest, Hungary
P. Stradins Clinical University Hospital
Riga, Latvia
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania
Medical University of Gdansk
Gdansk, Poland
Szpital Kliniczny Przemiemienia Panskiego
Poznan, Poland
Pomeranian Medical University Hospital no. 2
Szczecin, Poland
Samodzielnym Publicznym Centralnym Szpitalem Klinicznym
Warsaw, Poland
Silesian Center for Heart Diseases
Zabrze, Poland