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

This study has been completed.
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by:
Biotronik France
ClinicalTrials.gov Identifier:
NCT00989326
First received: October 2, 2009
Last updated: June 23, 2010
Last verified: October 2009
  Purpose

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).


Condition Intervention
Pacemaker, Artificial
Bradycardia
Other: Home Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Comparative Follow-up Schedule With Home Monitoring

Resource links provided by NLM:


Further study details as provided by Biotronik France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of Home Monitoring to detect pacemaker dysfunction [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Reduction of associated cost [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Delay of Home Monitoring to manage adverse events [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 543
Study Start Date: December 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Remote 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989326

Locations
France
CHU Pontchaillou de Rennes
Rennes, France, 35033
Sponsors and Collaborators
Biotronik France
Biotronik SE & Co. KG
Investigators
Principal Investigator: Philippe P MABO, Pr, Dr CHU Pontchaillou de Rennes
  More Information

No publications provided by Biotronik France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nicolas Canot, Biotronik France
ClinicalTrials.gov Identifier: NCT00989326     History of Changes
Other Study ID Numbers: HS037
Study First Received: October 2, 2009
Last Updated: June 23, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Biotronik France:
Remote monitoring
Pacemaker
Follow up
Follow-up studies

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014