At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,327 enrolled
Drug / intervention
BIOTRONIK Home Monitoring System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of the Safety and Efficacy of the Management of Pacemaker Patients Followed-up Via Home Monitoring vs. Conventional In-Office Follow-up
In Brief
A clinical study evaluating BIOTRONIK Home Monitoring System and BIOTRONIK Home Monitoring System with In-office Follow-up for Bradyarrhythmia. Completed, enrolled 1,327 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBradyarrhythmia
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedFeb 2012
Primary CompletionFeb 2016
TodayJul 2026
First PostedFeb 1, 2012
Enrollment StartJan 1, 2012
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.4 years ago
Interventions
BIOTRONIK Home Monitoring Systemdevice
Home Monitoring system transfers implantable device's data to the main server via internet.
BIOTRONIK Home Monitoring System with In-office Follow-updevice