Safety and Efficacy Study of IPG Patient With Home Monitoring

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.

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.

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.