Key Results
Key Result 1
COMPAS demonstrated a 66% reduction in hospitalizations for atrial arrhythmia and related stroke in the Home Monitoring group.
COMPAS Clinical Trial
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 2
COMPAS showed comparable safety event rates in both groups.
Key Result 3
COMPAS demonstrated that BIOTRONIK Home Monitoring® reduced the number of interim in-office follow-ups by 56 %
Key Result 4
At the same time, follow-ups were more often clinically actionable, resulting in pacemaker reprogramming or medication changes.
Clinical Relevance
- The COMPAS trial results demonstrate that BIOTRONIK Home Monitoring® is a safe and highly effective follow-up method for pacemaker patients.
- Bradycardia patients are often at risk of atrial fibrillation and thus stroke. COMPAS shows that an early reaction due to daily remote monitoring can actually reduce hospitalizations for atrial arrhythmia and related stroke.
- COMPAS and RM-ALONE are the basis for a Class IIa recommendation for spacing in-office follow-ups up to 24 months when patients are remotely monitored (2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy).
Study Details
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 who have 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