COMPAS

COMPAS

A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial)

MABO P ET AL., EUROPEAN HEART JOURNAL, 2012

Study Design

  • Multi-center, prospective, large-scale, randomized clinical trial

  • 538 patients in 43 French centers

  • To evaluate the effects and determine the benefits of long-term follow-up with BIOTRONIK Home Monitoring® on safety and effectiveness in pacemaker patients

Key Result 1

COMPAS demonstrated a 66% reduction in hospitalizations for atrial arrhythmia and related stroke in the Home Monitoring group.

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Key Result 2

COMPAS showed comparable safety event rates in both groups.

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Key Result 3

COMPAS demonstrated that BIOTRONIK Home Monitoring® reduced the number of interim in-office follow-ups by 56 %

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Key Result 4

While at the same time making these follow-ups more often clinically actionable, i.e. resulting in pacemaker reprogramming or medication changes.

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Clinical Relevance

  • The COMPAS trial results demonstrate that BIOTRONIK Home Monitoring® is a safe and highly effective follow-up method for pacemaker patients.
  • BIOTRONIK Home Monitoring® reduces the follow-up burden of overloaded clinics by enabling physicians to focus on patients who are more critically in need of medical attention.
  • BIOTRONIK Home Monitoring® enhances patient safety by enabling physicians to intervene earlier in case of a clinically relevant event.

Study Objective
  • To evaluate the effects and determine the benefits of long-term follow-up with BIOTRONIK Home Monitoring® on safety and effectiveness in pacemaker patients
Primary Endpoint
  • Number of patients with serious adverse events detected during and at the end of an 18 months follow-up period is compared for the two groups
Major Secondary Endpoints
  • Incidence of each type of MAE
  • Reduction in number of in-office follow-ups
  • Contributions of in-office follow-ups (clinical actionability)
  • Delay in the management of adverse events
  • Impact of Home Monitoring on patient’s quality of life
Clinical Sites
  • 43 centers (France)
Sample Size
  • 538 patients
Main Inclusion Criteria
  • Patients undergone implantation of a PHILOS II DR-T DDD pacemaker (Biotronik SE and Co. KG, Berlin, Germany) with an A/V bipolar lead, for standard pacing indications, at least 1 month earlier
  • Patients were able to (a) comply with the study protocol and (b) sign an informed consent
Main Exclusion Criteria
  • Patients with spontaneous ventricular rate <30 b.p.m
Study Flowchart
    Follow-Up
    • 18 months
    Study Duration
    • Between December 2005 and January 2008
    Reference no.
    • NCT00989326
    Principal Investigators
    • Philippe P. Mabo, Pr, Dr (CHU Pontchaillou de Rennes, France)