Status:
COMPLETED
Safety and Efficacy Study of IPG Patient With Home Monitoring
Lead Sponsor:
Biotronik Japan, Inc.
Conditions:
Bradyarrhythmia
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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 ...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
1327 Patients enrolled
Trial Details
Trial ID
NCT01523704
Start Date
January 1 2012
End Date
February 1 2016
Last Update
January 27 2021
Active Locations (1)
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1
Fujita Health University
Toyoake, Aichi-ken, Japan, 4701192