Evaluate the Benefits of Pacemaker Follow-Up With Home-Monitoring (COMPAS)

Comparative Follow-up Schedule With Home Monitoring

The study investigates whether home monitoring follow-up of Pace-Maker patients is as efficient as conventional method in terms of Significant Serious Adverse Event (SSAE).

Study Overview

• Status: Completed
• Conditions: Bradycardia; Pacemaker, Artificial
• Intervention / Treatment: Other: Home Monitoring

Detailed Description

Due to its integrated long-distance telemetry, the implantable pacemaker Philos II DR-T is capable of periodically transmitting data from the pacemaker memory to the BIOTRONIK Service Center via patient device. The BIOTRONIK Service Center decodes the data and presents it to the physician on a password secured internet site. Additionally, in case certain event criteria are met, the most important Home Monitoring information are immediately faxed to the physician as an Event Report. These events can be customised by the physician. Thus, the physician will be able to closely monitor the patient and check the adequacy and efficiency of the pacemaker therapy without requiring the patient to visit the physician. The transmitted data comprise information on atrial and ventricular rhythm, atrioventricular conduction and system status.

The purpose of the national prospective, randomized, multicentric clinical study "COMPArative follow-up Schedule with home monitoring" (COMPAS) described here is to evaluate the benefits of pacemaker follow-up with home monitoring in France. The standard follow-up or therapeutic intervention will be deemed based on faxed event Reports reception and Cardio reports analysis on internet site. During the clinical study, the incidence of serious adverse events (hospitalisation, pacemaker dysfunction, and cardiovascular events), economic impact, safety, and practicability will be analysed. The findings from the ACTIVE group will be compared to those of a group receiving standard of care (CONTROL group). Both patient groups are followed for 18 months and will be followed with Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.

The trial will be conducted as a prospective, randomised, open, multicenter, national clinical trial. The enrollment of 400 patients in 50 clinical centres in France is anticipated. The principal inclusion criterion is indication for dual chamber pacemaker/ICD implantation. Main exclusion criteria comprise pacemaker dependency.

• Study Type: Interventional
• Enrollment (Actual): 543
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • CHU Pontchaillou de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient is willing and able to comply with the protocol
• The patient has provided written informed consent
• Patient whose medical situation is stable
• Patient with PHILOS II DR-T Pacemaker >= one month with A/V bipolar lead
• No change of residence expected during study

Exclusion Criteria:

• Spontaneous Ventricular Rhythm < 30 ppm
• Heart failure no controlled by medical treatment
• Post cardiac surgery (< 1 month)
• Post myocardial infarction (< 1 month)
• More than two cardioversion shocks for last 6 month
• A/V Lead dislodgement, or/and impedance, threshold, or sensing failure
• Pocket hematoma with needed intervention
• Pneumothorax / Hemothorax
• Infection
• Automatic Ventricular Threshold Test cannot be realised
• Patient unable to handle Home Monitoring system correctly
• Insufficient GSM coverage at patient's home
• Participation in another clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CONTROL group; The patients receive standard of care for 18 months. The CONTROL group patients will be equipped with Home Monitoring. However, the Home Monitoring data will not be used for patient surveillance; i. e. the patient will be followed in the conventional manner.	Other: Home Monitoring; Both patient groups are followed for 18 months and will be followed with Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.; Other Names: Remote monitoring
Experimental: ACTIVE group; The patients are followed by Home monitoring only. Every patient must be seen by his physician 18 months after enrolment for regular follow-up. Within this period, the additional Pace Maker follow-up or therapeutic intervention will be primarily triggered on cardio-reports reception or patient/physician call	Other: Home Monitoring; Both patient groups are followed for 18 months and will be followed with Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.; Other Names: Remote monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy of Home Monitoring to detect pacemaker dysfunction	18 months
Reduction of associated cost	18 months
Delay of Home Monitoring to manage adverse events	18 months

Collaborators and Investigators

• Sponsor: Biotronik France
• Collaborators: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Philippe P MABO, Pr, Dr, CHU Pontchaillou de Rennes

Publications and helpful links

General Publications

• Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, Binet D, Daubert JC; COMPAS Trial Investigators. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J. 2012 May;33(9):1105-11. doi: 10.1093/eurheartj/ehr419. Epub 2011 Nov 29.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: October 2, 2009
• First Submitted That Met QC Criteria: October 2, 2009
• First Posted (Estimate): October 5, 2009

Study Record Updates

• Last Update Posted (Estimate): June 24, 2010
• Last Update Submitted That Met QC Criteria: June 23, 2010
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Follow up; Remote monitoring; Pacemaker; Follow-up studies
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: HS037