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Safety and Efficacy Study of IPG Patient With Home Monitoring

Primary Purpose

Bradyarrhythmia

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
BIOTRONIK Home Monitoring System
BIOTRONIK Home Monitoring System with In-office Follow-up
Sponsored by
Biotronik Japan, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradyarrhythmia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fujita Health University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home Monitoring(HM)

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
January 26, 2012
Last Updated
January 7, 2021
Sponsor
Biotronik Japan, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01523704
Brief Title
Safety and Efficacy Study of IPG Patient With Home Monitoring
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik Japan, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradyarrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home Monitoring(HM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BIOTRONIK Home Monitoring System
Intervention Description
Home Monitoring system transfers implantable device's data to the main server via internet.
Intervention Type
Device
Intervention Name(s)
BIOTRONIK Home Monitoring System with In-office Follow-up
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The Median (IQR) Numbers of In-office Follow-up（FU) Visits Per Patient-year
Description
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
Time Frame
2 years
Title
Efficacy of Home Monitoring：Average Cost for In-office Follow-up Per Patient-year
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eiichi Watanabe, MD
Organizational Affiliation
Fujita Health University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujita Health University
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
4701192
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32342703
Citation
Watanabe E, Yamazaki F, Goto T, Asai T, Yamamoto T, Hirooka K, Sato T, Kasai A, Ueda M, Yamakawa T, Ueda Y, Yamamoto K, Tokunaga T, Sugai Y, Tanaka K, Hiramatsu S, Arakawa T, Schrader J, Varma N, Ando K. Remote Management of Pacemaker Patients With Biennial In-Clinic Evaluation: Continuous Home Monitoring in the Japanese At-Home Study: A Randomized Clinical Trial. Circ Arrhythm Electrophysiol. 2020 May;13(5):e007734. doi: 10.1161/CIRCEP.119.007734. Epub 2020 Apr 28.
Results Reference
derived

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Safety and Efficacy Study of IPG Patient With Home Monitoring

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