Moderato System: A Double-Blind Randomized Trial Ver 1.1

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.

Conditions

• Hypertension Resistant to Conventional Therapy
• Bradycardia
• Atrioventricular Block

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.

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

2016-07-12

Primary Completion

2019-08-31

Completion

2023-03-31

Countries

• Austria
• Belgium
• Czechia
• Hungary
• Latvia
• Lithuania
• Poland

Study Locations