NCT00989326

Evaluate the Benefits of Pacemaker Follow-Up With Home-Monitoring

Comparative Follow-up Schedule With Home Monitoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 543 (actual)
• Sponsor: Biotronik France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

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.

Conditions

• Pacemaker, Artificial
• Bradycardia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-10-05
• Last updated: 2010-06-24

Locations

1 site across 1 country: France