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

Bradycardia Clinical Trial

— COMPAS  

Official title:

Comparative Follow-up Schedule With Home Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989326
• Other study ID #: HS037
• Status: Completed
• Phase: N/A
• First received: October 2, 2009
• Last updated: June 23, 2010
• Start date: December 2005
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Biotronik France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bradycardia
• Pacemaker, Artificial

Intervention

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.

Locations

Country	Name	City	State
France	CHU Pontchaillou de Rennes	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik France	Biotronik SE & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		18 months	Yes
Secondary	Efficacy of Home Monitoring to detect pacemaker dysfunction		18 months	Yes
Secondary	Reduction of associated cost		18 months	Yes
Secondary	Delay of Home Monitoring to manage adverse events		18 months	No