At-Home Clinical Trial

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
doi: 10.1161/CIRCEP.119.007734

Study Design

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 alerts notified by HM
24 months follow-up duration

Key Results

Key Result 1

The At-Home study demonstrated non-inferiority of exclusive remote follow-up over 2 years in comparison to continuous remote monitoring associated with in-office follow-ups for real-world pacemaker patients.

Figure 1: Kaplan-Meier curves of incidence of primary endpoints (a composite of death, stroke, or cardiovascular surgical procedure), starting at randomization. RFU, remote follow-up; CFU, conventional follow-up.

At home Key result 1

Key Result 2

The median (IQR) number of in-office follow-ups was 0.50 (0.50 – 0.63) in RFU and 2.01 (1.93 – 2.05) in CFU per patient-year (P<0.001).

At home Key result 2

Clinical Relevance

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.

Study Details

Study Objective

To study safety and resource consumption of exclusive remote follow-up (RFU) in pacemaker patients for two years.

Primary Endpoint

Composite of death, stroke or cardiovascular procedure

Major Secondary Endpoints

Number of in-office follow-ups
Cost to medical insurance

Clinical Sites

85 Japanese institutions

Sample Size

1274 participants

Main Inclusion Criteria

At least 20 years old
Pacemaker indication according to Japanese guidelines
Biotronik pacemaker equipped with Home Monitoring®
Willing and able to comply to study procedures including daily automatic RM surveillance
Geographically stable and likely to return for in-office evaluations over a follow-up period of 27 month

Main Exclusion Criteria

Life expectancy shorter than 27 months
Likelihood of undergoing heart transplant within 27 months
Participation in another cardiology study

Study Flowchart

At home Key Flowchart

Follow-Up

24 months

Study Duration

January 2012 to February 2016

Reference no.

NCT01523704

Principal Investigators

Eiichi Watanabe
Fujita Health University School of Medicine, Japan

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