Remote Management of Pacemaker Patients with Biennial In-clinic evaluation: Continuous Home Monitoring in the Japanese at Home Study. A Randomized Clinical Trial
Watanabe E ET AL., CIRCEP 2020 May;13(5):e007734
- Large, prospective, randomized, controlled, multicenter study
- 1274 consecutive pacemaker patients at 85 centers in Japan
- Single- or dual chamber pacemaker indication according to Japanese guidelines
- BIOTRONIK Evia devices
- 1:1 randomization to Home Monitoring+remote follow-up or Home Monitoring+in-office follow-up
- Regular biannual follow-ups in both arms
- If needed, unscheduled in-office follow-ups initiated by patients or physicians or due to or due to alerts notified by HM
- 24 months follow-up duration
- The At-Home study is the largest randomized trial to investigate pacemaker patient follow-up with Home Monitoring only for 2 years.
- Follow-up of cardiovascular implantable electronic devices is the most frequent activity reported by cardiac electrophysiologists. By exclusively using Home Monitoring, the proportion of in-office follow-ups can be significantly reduced for pacemaker patients.
- Before At-Home, the main concern about extending the time between in-office follow-ups was that safety could be compromised. The At-Home results indicate that surveillance of a real-world pacemaker patient population exclusively based on Home Monitoring for 2 years is safe.
- The At-Home results indicate that reducing the need for in-office follow-ups reduces the resource consumption of managing pacemaker patients.
|Major Secondary Endpoints||
|Main Inclusion Criteria||
|Main Exclusion Criteria||