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

Biotronik

Status: Completed

Conditions: Bradycardia; Pacemaker, Artificial

Treatments: Other: Home Monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989326

HS037

Details and patient eligibility

About

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).

Full 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.

Enrollment: 543 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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543 participants in 2 patient groups

CONTROL group

Active Comparator group

Description:

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.

Treatment:

Other: Home Monitoring

ACTIVE group

Experimental group

Description:

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

Treatment:

Other: Home Monitoring