Safety and Efficacy Study of IPG Patient With Home Monitoring

This study is currently recruiting participants.
Verified January 2012 by Biotronik Japan, Inc.
Sponsor:
Information provided by (Responsible Party):
Biotronik Japan, Inc.
ClinicalTrials.gov Identifier:
NCT01523704
First received: January 26, 2012
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Average cost for in-office follow-up will be compared between two groups.


Estimated Enrollment: 1364
Study Start Date: January 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523704

Contacts
Contact: Ruiko Yokoyama +81-3-3473-7478 ruiko.yokoyama@biotronik.co.jp

Locations
Japan
Fujita Health University Recruiting
Toyoake, Aichi, Japan, 4701192
Contact: Eiichi Watanabe, MD       enwatan@fujita-hu.ac.jp   
Principal Investigator: Kenji Ando         
Sponsors and Collaborators
Biotronik Japan, Inc.
Investigators
Principal Investigator: Eiichi Watanabe, MD Fujita Health University
  More Information

No publications provided

Responsible Party: Biotronik Japan, Inc.
ClinicalTrials.gov Identifier: NCT01523704     History of Changes
Other Study ID Numbers: atHome Study
Study First Received: January 26, 2012
Last Updated: January 30, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014