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Updated: Apr 18, 2026
A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program
Published on: April 19, 2019
A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial)
Philippe Mabo1, Frédéric Victor, Patrick Bazin
1Centre Hospitalier Universitaire Pontchaillou, 2 Rue Henri Le Guilloux, Rennes 35000, France. philippe.mabo@chu-rennes.fr
Insights
Remote monitoring of pacemakers is a safe alternative to standard care, significantly reducing healthcare burdens. This approach lowers ambulatory visits for pacemaker patients without compromising their quality of life.
Area of Science:
- Cardiology
- Medical Devices
- Health Informatics
Background:
- Professional guidelines advocate regular follow-up for pacemaker recipients.
- Conventional ambulatory visits are often unproductive and strain healthcare resources.
Purpose of the Study:
- To evaluate the safety and efficacy of long-term remote monitoring for pacemaker patients.
- To compare remote monitoring with standard care in terms of major adverse events and healthcare utilization.
Main Methods:
- A randomized, multicenter, non-inferiority trial (COMPAS) involving 538 patients.
- Patients were assigned to remote monitoring (active group) or standard care (control group).
- Primary endpoint: proportion of patients with major adverse events (MAE) over 18.3 months.
Main Results:
- Non-inferiority was confirmed, with 17.3% MAE in the active group vs. 19.1% in the control group (P < 0.01).
- The active group had fewer hospitalizations for atrial arrhythmias and strokes.
- Remote monitoring reduced ambulatory visits by 56% and increased necessary interventions during visits.
Conclusions:
- Remote monitoring is a safe alternative to conventional follow-up for pacemaker patients.
- It significantly decreases the number of ambulatory visits required.
- No significant changes in quality of life were observed between groups.
Aims:
Professional practice guidelines recommend that pacemaker recipients be followed regularly. However, the majority of scheduled ambulatory visits is unproductive and imposes a heavy burden on the health-care system.
Methods And Results:
The COMPAS randomized, multicentre, non-inferiority trial examined the safety of long-term remote monitoring of pacemakers. Between December 2005 and January 2008, 538 patients were randomly assigned to remote monitoring follow-up (active group) vs. standard care (control group). The primary objective was to confirm that the proportion of patients who experienced at least one major adverse event (MAE), including all-cause death and hospitalizations for device-related or cardiovascular adverse events, was not >7% higher in the active than in the control group. MAE-free survivals and quality of life were compared in both groups. The characteristics of the study groups were similar. Over a follow-up of 18.3 months, 17.3% of patients in the active and 19.1% in the control group experienced at least one MAE (P < 0.01 for non-inferiority). Hospitalizations for atrial arrhythmias (6 vs. 18) and strokes (2 vs. 8) were fewer (P < 0.05), and the number of interim ambulatory visits was 56% lower (P < 0.001) in the active than the control group. Changes in pacemaker programming or drug regimens were made in 62% of visits in the active vs. 29% in the control group (P < 0.001). Quality of life remained unchanged in both groups.
Conclusion:
Remote monitoring was a safe alternative to conventional care and significantly lowered the number of ambulatory visits during long-term follow-up of permanently paced patients. ClinicalTrials.gov identifier: NCT00989326.
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