Safety and Efficacy Study of IPG Patient With Home Monitoring

Biotronik

Status: Completed

Conditions: Bradyarrhythmia

Treatments: Device: BIOTRONIK Home Monitoring System; Device: BIOTRONIK Home Monitoring System with In-office Follow-up

Study type: Interventional

Funder types: Industry

Identifiers

NCT01523704

atHome Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,327 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,327 participants in 2 patient groups

Home Monitoring(HM)

Experimental group

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.

Treatment:

Device: BIOTRONIK Home Monitoring System

Control

Active Comparator group

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.

Treatment:

Device: BIOTRONIK Home Monitoring System with In-office Follow-up