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

Related Link and Download

Link to Publication

Remote Management of Pacemaker Patients With Biennial In-Clinic Evaluation

Download

At-Home Leaflet