Moderato System in Patients With Hypertension

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.

Conditions

• Hypertension, Resistant to Conventional Therapy
• Atrioventricular Block

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.

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• MLM Medical Labs GmbH

  collaborator INDUSTRY

• nabios GmbH

  collaborator UNKNOWN

• BackBeat Medical Inc

  lead INDUSTRY

Principal Investigators

• Karl-Heinz Kuck, Prof. MD · Asklepios Klinik St. Georg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-30

Primary Completion

2021-02-01

Completion

2023-03-30

Countries

• Belgium
• Lithuania
• Poland

Study Locations