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TERMINATED
NCT03757377
NA

Moderato System in Patients With Hypertension

Sponsor: BackBeat Medical Inc

View on ClinicalTrials.gov

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

DEVICE

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

DEVICE

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