Safety and Efficacy Study of IPG Patient With Home Monitoring

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bradyarrhythmia

Intervention / Treatment
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* Device: BIOTRONIK Home Monitoring System
* Device: BIOTRONIK Home Monitoring System with In-office Follow-up


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Monitoring(HM)<br>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<br>* Home Monitoring system transfers implantable device's data to the main server via internet.<br>|
| Active Comparator: Control<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation for Equivalence of the Number of Patients Who Meet the Composite Safety Endpoint Between Home Monitoring Group(HM) and Control Group Which is HM + Conventional In-office Follow-up | The purpose of the 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 (e.g. device explants or lead revision) between HM Group and Control Group. Safety will be evaluated in the following testable hypothesis in an equivalence (non-inferiority) format: HØ: The safety event rate (SER) for a 24-month duration for Group 1 is not equivalent to the SER for Group 2. SER Group 1 - SER Group 2 ≥ Ha : The safety event rate (SER) for a 12-month duration for Group 1 is equivalent to the SER for Group 2 SER Group 1 - SER Group 2 < Where, ( )represents the allowable clinically significant difference. 5% was set for the study. A rejection of the null hypothesis (HØ) will indicate that the safety event rate for Group 1 is equivalent (non-inferior) to that of Group 2. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Median (IQR) Numbers of In-office Follow-up（FU) Visits Per Patient-year | Average numbers of outpatient follow-up(FU)s per patient are compared between Home Monitoring(HM) group and the control group, assessing total numbers of outpatient FUs combining regular and additional FUs. If the average number of visits in HM group is significantly less than that in Control group, it would serve as supporting evidence that the number of outpatient FUs can be reduced with HM. Analysis is performed on those patients that had a regular 3 months-FU following Intention to treat(ITT) principle. The analysis population of endpoint can be expected to be larger than the analysis population of the primary endpoints because patients with drop-out after the 3-months FU, but before the 27 months-FU will be included. The numbers of FU visits that occur in the 2 groups during the study period are compared as follows: AveN Group 1= Average number of FU visits per 2 years in the HM group AveN Control= Average number of FU visits per 2 years in the control group | 2 years | 
| Efficacy of Home Monitoring：Average Cost for In-office Follow-up Per Patient-year | The sum of insured medical expenses for regular and additional outpatient FUs will be compared between HM group and Control group. It shall include Fees of FU consultation, cardiac IPG instruction, and other diagnostic test , but treatment fees including medication. Hospitalization are not included. This analysis is performed on the same ITT population as the analysis set of the first secondary endpoint. To compensate for possible asymmetric drop-out, the comparison will not be cost per patient, but costs per patient-year. Study costs per patient will be calculated by summing up all relevant variables in 3mFU Randomization CRF (points2-11) as well as in InOffice FU CRF and in Additional InOffice FU CRF. Total costs per patient result by multiplying the sum of all points by 10. Unit measurement is Yen. H : The average costs in HM group are not less than that in Control group. AveCostsHM ≥ AveCostsControl Ha: The average costs in HM group are less than that in Control group. | 2 years |