ECOST Clinical Trial

Study Objective

• Examination of the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators

Primary Endpoint

• The proportion of patients who experienced ≥ 1 MAE, including death from any cause, cardiovascular and procedure or device related MAE

Major Secondary Endpoints

• Appropriate and inappropriate shock deliveries
• ICD capacitor charges
• Impact on battery longevity

Clinical Sites

• 43 centers

Sample Size

• 433 patients

Main Inclusion Criteria

• Indication for single or dual chamber ICD

Main Exclusion Criteria

• NYHA class IV
• Pregnant woman or woman who plan to become pregnant during the trial
• Patient whose medical situation is not stable
• Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea > 70mg/dl or creatinine >3mg/dl), liver failure, etc.
• Age < 18 years
• Patient unable to handle Home Monitoring system correctly
• The patient is not willing and able to comply with the protocol
• Change of residence expected during study
• Insufficient GSM coverage at patient's home
• Participation in another clinical study
• Patient unwilling to sign the consent for participation

Devices

• ICDs equipped with BIOTRONIK Home Monitoring

Study Flowchart

Follow-Up

• 27 months follow-up

Study Duration

• January 2007 – October 2010

Reference no.

• NCT00989417

Principal Investigators

• Prof. Dr. Salem S. Kacet