NCT01523704

Safety and Efficacy Study of IPG Patient With Home Monitoring

Comparison of the Safety and Efficacy of the Management of Pacemaker Patients Followed-up Via Home Monitoring vs. Conventional In-Office Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,327 (actual)
• Sponsor: Biotronik Japan, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Bradyarrhythmia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2012-02-01
• Last updated: 2021-01-27
• Results posted: 2021-01-27

Locations

1 site across 1 country: Japan