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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

Key Result

Remote follow-up with BIOTRONIK Home Monitoring® is as safe as conventional ambulatory follow-up.

ECOST Key result

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

ECOST Flowchart

Follow-Up

  • 27 months follow-up

Study Duration

  • January 2007 – October 2010

Reference no.

  • NCT00989417

Principal Investigators

  • Prof. Dr. Salem S. Kacet

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