BradyarrhythmiaNCT01523704
Safety and Efficacy Study of IPG Patient With Home Monitoring
A study testing BIOTRONIK Home Monitoring System and BIOTRONIK Home Monitoring System with In-office Follow-up in people with Bradyarrhythmia, run by Biotronik Japan, Inc. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bradyarrhythmia
- What is being tested?
- BIOTRONIK Home Monitoring System and BIOTRONIK Home Monitoring System with In-office Follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,327 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- BIOTRONIK Home Monitoring System, BIOTRONIK Home Monitoring System with In-office Follow-up
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Home Monitoring(HM) | Experimental | 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. Receives: Device: BIOTRONIK Home Monitoring System |
| Control | Active comparator | 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. Receives: Device: BIOTRONIK Home Monitoring System with In-office Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
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
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradyarrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik Japan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eiichi Watanabe, MD, Principal investigator, Fujita Health University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523704
- Sponsor's protocol ID
- atHome Study
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2012
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32342703
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01523704
- Acronym / sponsor ID
- atHome Study
- Conditions
- Bradyarrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,327 participants (actual)
- Lead sponsor
- Biotronik Japan, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 27 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Monitoring(HM) | Experimental | Device: BIOTRONIK Home Monitoring SystemPatients 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. |
| Control | Active comparator | Device: BIOTRONIK Home Monitoring System with In-office Follow-upPatients 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOTRONIK Home Monitoring SystemHome Monitoring system transfers implantable device's data to the main server via internet. | Device | Home Monitoring(HM) |
| BIOTRONIK Home Monitoring System with In-office Follow-up | Device | Control |
Primary outcome
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
Time frame: 2 years
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 secondary outcomes
The Median (IQR) Numbers of In-office Follow-up（FU) Visits Per Patient-year
Time frame: 2 years
Efficacy of Home Monitoring：Average Cost for In-office Follow-up Per Patient-year
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32342703Watanabe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eiichi Watanabe, MD principal investigator
Fujita Health University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOTRONIK Home Monitoring System and BIOTRONIK Home Monitoring System with In-office Follow-up in people with Bradyarrhythmia, run by Biotronik Japan, Inc. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01523704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.