N/A
Completed N=1,274
Safety and Efficacy Study of IPG Patient With Home Monitoring
Bradyarrhythmia
Source: ClinicalTrials.gov NCT01523704 ↗
Enrolled (actual)
1,274
Serious AEs
12.3%
Results posted
Jan 2021
Primary outcomePrimary: 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 — 61; 65 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
61; 65 | — |
| SECONDARY The Median (IQR) Numbers of In-office Follow-up（FU) Visits Per Patient-year |
0.69; 2.00 | — |
| SECONDARY Efficacy of Home Monitoring：Average Cost for In-office Follow-up Per Patient-year |
21065; 23552 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01523704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.