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

Tracking Information
First Submitted Date ICMJE	October 2, 2009
First Posted Date ICMJE	October 5, 2009
Last Update Posted Date	June 24, 2010
Study Start Date ICMJE	December 2005
Actual Primary Completion Date	October 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 2, 2009)	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 [ Time Frame: 18 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00989326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 2, 2009)	Efficacy of Home Monitoring to detect pacemaker dysfunction [ Time Frame: 18 months ]; Reduction of associated cost [ Time Frame: 18 months ]; Delay of Home Monitoring to manage adverse events [ Time Frame: 18 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Evaluate the Benefits of Pacemaker Follow-Up With Home-Monitoring
Official Title ICMJE	Comparative Follow-up Schedule With Home Monitoring
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
Condition ICMJE	Pacemaker, Artificial; Bradycardia
Intervention ICMJE	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 Name: Remote monitoring
Study Arms	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. Intervention: Other: Home 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 Intervention: Other: Home Monitoring
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 2, 2009)	543
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	October 2009
Actual Primary Completion Date	October 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00989326
Other Study ID Numbers ICMJE	HS037
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Nicolas Canot, Biotronik France
Study Sponsor ICMJE	Biotronik France
Collaborators ICMJE	Biotronik SE & Co. KG
Investigators ICMJE	Principal Investigator: Philippe P MABO, Pr, Dr CHU Pontchaillou de Rennes
PRS Account	Biotronik France
Verification Date	October 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP