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TERMINATED
NCT02837445
NA

Moderato System: A Double-Blind Randomized Trial Ver 1.1

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. 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

DEVICE

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

DEVICE

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