Overview

This trial is active, not recruiting.

Condition bradyarrhythmia
Treatments biotronik home monitoring system, biotronik home monitoring system with in-office follow-up
Sponsor Biotronik Japan, Inc.
Start date January 2012
End date August 2015
Trial size 1364 participants
Trial identifier NCT01523704, atHome Study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
biotronik home monitoring system
Home Monitoring system transfers implantable device's data to the main server via internet.
(Active Comparator)
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.
biotronik home monitoring system with in-office follow-up

Primary Outcomes

Measure
Home Monitoring Safety
time frame: 2 years

Secondary Outcomes

Measure
Efficacy of Home Monitoring
time frame: 2 years
Efficacy of Home Monitoring
time frame: 2 years

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

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
Principal investigator Eiichi Watanabe, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Biotronik Japan, Inc..