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Safety and Efficacy Study of IPG Patient With Home Monitoring

This study has been completed.
Information provided by (Responsible Party):
Biotronik Japan, Inc. Identifier:
First received: January 26, 2012
Last updated: February 3, 2017
Last verified: February 2017

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.

Patients will be randomized into HM follow-up only (Group 1) or HM & in-office follow-up (Group 2) and will be followed-up for 27 months.

Condition Intervention
Bradyarrhythmia Device: BIOTRONIK Home Monitoring System Device: BIOTRONIK Home Monitoring System with In-office Follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Safety and Efficacy of the Management of Pacemaker Patients Followed-up Via Home Monitoring vs. Conventional In-Office Follow-up

Further study details as provided by Biotronik Japan, Inc.:

Primary Outcome Measures:
  • Home Monitoring Safety [ Time Frame: 2 years ]
    The purpose of primary endpoint is to compare the composite safety endpoint, Safety Event Rate (SER) which includes death, incidence of strokes and cardiovascular related serious adverse events requiring surgical interventions.

Secondary Outcome Measures:
  • Efficacy of Home Monitoring [ Time Frame: 2 years ]
    Number of in-office IPG follow-up will be compared between two groups to evaluate the efficacy of Home Monitoring System

  • Efficacy of Home Monitoring [ Time Frame: 2 years ]
    Average cost for in-office follow-up will be compared between two groups.

Enrollment: 1333
Study Start Date: January 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HM
Patients assigned to HM Group(HM follow-up ONLY) will have Home Monitoring programmed ON. They will be seen in the office for device interrogations at the 3-month follow-up, and at 27 month follow-up. In the meanwhile the device status will be evaluated using HM only for the 9, 15 and 21 month scheduled follow-up. Patients will visit the hospital for device interrogation on 27 month final follow-up.
Device: BIOTRONIK Home Monitoring System
Home Monitoring system transfers implantable device's data to the main server via internet.
Active Comparator: Control
Patients assigned to Control Group (HM + Conventional In-office follow-up - Control group) will have HM programmed ON. In addition to HM, these patients will visit the hospital for device interrogation at 3, 9, 15, 21 and 27 month follow-ups.
Device: BIOTRONIK Home Monitoring System with In-office Follow-up


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Indicated for IPG implantation under Japanese guidelines
  • Implanted within the last 45 days or being considered for implant with a BIOTRONIK IPG with Home Monitoring
  • Able to utilize HM system throughout the study
  • Ability to give informed consent
  • Geographically stable and able to return for follow-ups for 27 months
  • Over 20 years old
  • Patient able to understand and follow the procedure stated in protocol

Exclusion Criteria:

  • Contraindicated for IPG under Japanese guidelines
  • Patients who are currently included in another cardiac clinical study
  • Patients with expected life period of less than two years
  • Patients who might undergo heart transplantation in next two years.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01523704

Fujita Health University
Toyoake, Aichi, Japan, 4701192
Sponsors and Collaborators
Biotronik Japan, Inc.
Principal Investigator: Eiichi Watanabe, MD Fujita Health University
  More Information

Responsible Party: Biotronik Japan, Inc. Identifier: NCT01523704     History of Changes
Other Study ID Numbers: atHome Study
Study First Received: January 26, 2012
Last Updated: February 3, 2017

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on August 23, 2017