Key Result
Remote follow-up with BIOTRONIK Home Monitoring® is as safe as conventional ambulatory follow-up.
ECOST Clinical Trial
Effectiveness and Costs of ICD Follow-up Schedule with Telecardiology
Laurence Guédon-Moreau, European Heart Journal 2013
Study Design
- Randomized, interventional, multicenter study
- Compares the safety of continuous BIOTRONIK Home Monitoring versus conventional ambulatory follow-up of ICDs
- 433 patients at 43 centers in France
Clinical Relevance
- The ECOST study shows that BIOTRONIK Home Monitoring of ICDs is a safe alternative to in-office follow-ups. It positively impacts patient outcome, specially when it comes to reducing the risk of inappropriate shocks.
Study Details
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