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Safety and Efficacy Study of IPG Patient With Home Monitoring

NCT01523704 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1327

Last updated 2021-01-27

Study results available
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Summary

The number of patients with implantable pulse generator (IPG) has steadily increased in Japan causing increment in number of in office follow-ups and greater burden on many hospitals.

The purpose of this multicenter randomized study is to demonstrate that BIOTRONIK Home Monitoring system reduces office follow-up visits without compromising patient safety.

Conditions

  • Bradyarrhythmia

Interventions

DEVICE

BIOTRONIK Home Monitoring System

Home Monitoring system transfers implantable device's data to the main server via internet.

DEVICE

BIOTRONIK Home Monitoring System with In-office Follow-up

Sponsors & Collaborators

  • Biotronik Japan, Inc.

    lead INDUSTRY

Principal Investigators

  • Eiichi Watanabe, MD · Fujita Health University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Japan

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 NCT01523704 on ClinicalTrials.gov