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Safety and Efficacy Study of IPG Patient With Home Monitoring

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ClinicalTrials.gov Identifier: NCT01523704
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Biotronik Japan, Inc.

Brief 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.

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 or disease Intervention/treatment Phase
Bradyarrhythmia Device: BIOTRONIK Home Monitoring System Device: BIOTRONIK Home Monitoring System with In-office Follow-up Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1333 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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

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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523704


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

Responsible Party: Biotronik Japan, Inc.
ClinicalTrials.gov Identifier: NCT01523704     History of Changes
Other Study ID Numbers: atHome Study
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

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