Clinical trial NCT00989326: Evaluate the Benefits of Pacemaker Follow-Up With Home-Monitoring
Official title: Comparative Follow-up Schedule With Home Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker, Artificial
Bradycardia
Keywords: Remote monitoring
Pacemaker
Follow up
Follow-up studies
Lead sponsor: Biotronik France
Sponsor class: INDUSTRY
Collaborators: name: Biotronik SE & Co. KG
First posted: 2009-10-05
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 18 months
Secondary outcomes:
measure: Efficacy of Home Monitoring to detect pacemaker dysfunction
timeFrame: 18 months
measure: Reduction of associated cost
timeFrame: 18 months
measure: Delay of Home Monitoring to manage adverse events
timeFrame: 18 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Pontchaillou de Rennes
Study officials:
affiliation: CHU Pontchaillou de Rennes
name: Philippe P MABO, Pr, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.