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Safety and Performance Study of the Moderato System

NCT02282033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2018-02-22

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce their blood pressure.

Conditions

  • Hypertension Resistant to Conventional Therapy
  • Bradycardia
  • Atrioventricular Block

Interventions

DEVICE

The Moderato System

The BackBeat Moderato System incorporates traditional pacing modes and algorithms to provide pacing support to patients with all conditions currently indicated for dual chamber pacing. In addition, a special pacing algorithm was developed to reduce blood pressure.

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. · Asklepios Klinik St. Georg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-11-30
Completion
2017-08-31

Countries

  • Austria
  • Chile
  • Czechia
  • Hungary
  • Latvia
  • Lithuania
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02282033 on ClinicalTrials.gov