Patients with implanted pacemaker device
Conditions
Interventions
None listed
Sponsors
Japan Lifeline Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients who meet the criterion of pacemaker implantation of the guideline for non-drug treatment for arrhythmia (revised in 2006) established by The Japan Circulation Society -Patients those SafeR mode can be programmed -Patients signed informed consent
Exclusion criteria
Exclusion criteria: -Patients who are not able to understand the purpose and protocol of the study -Patients who are not able to come to the follow-up and those the investigator determines not eligible for the study -Patients with any contraindication or/and who have possibility of being in the status of the warning stated in the package insert of the device -Age of less than 20 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that percentages of ventricular pacing significantly decrease during SafeR mode more than during DDD mode | — |
Secondary
| Measure | Time frame |
|---|---|
| -Number of times and operating duration of mode-switch by SafeR mode -Number of times of PAC and PVC occurred during follow-up period -Clinical observation and record during follow-up period (indication for implantation, underlying cardiac disease, preexisting arrhythmia, medical history and data of pacing leads at each follow-up, etc.) | — |
Countries
Japan
Contacts
Public ContactKenjiro Hara
Japan Lifeline Co., Ltd. Cardiac Rhythm Management Division
Outcome results
None listed