Safety and Efficacy Study of IPG Patient With Home Monitoring
|ClinicalTrials.gov Identifier: NCT01523704|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 6, 2017
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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|
- 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.
- 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
- Efficacy of Home Monitoring [ Time Frame: 2 years ]Average cost for in-office follow-up will be compared between two groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523704
|Fujita Health University|
|Toyoake, Aichi, Japan, 4701192|
|Principal Investigator:||Eiichi Watanabe, MD||Fujita Health University|