Ventricular Fibrillation Clinical Trial
— ECOSTOfficial title:
Effectiveness and Cost Of ICD Follow-up Schedule With Telecardiology
In many aspects of every-day life, modern communication systems bring about a remarkable increase in comfort and safety by transmitting data and information in an easy and reliable manner. In order to provide these advantages also to patients with implantable cardioverter-defibrillators, as well as to their physicians, BIOTRONIK has developed a long-distance implant telemetry to enable periodic trend and event-triggered transmissions of implant data and intracardiac electrogram over distances of several meters. The data is received by a patient device and subsequently automatically transferred to a BIOTRONIK Service Center that provides it to the physician on a password secured internet site. Hence, the physician receives diagnostic information without the patient having to visit the physician (Home Monitoring, HM). New possibilities will arise for a detailed medical and event-correlated supervision of the patient's therapy using electrically active implants.
Status | Completed |
Enrollment | 473 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Indication for single or dual chamber ICD 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
France | CHRU de Lille- Hôpital Cardiologique | Lille |
Lead Sponsor | Collaborator |
---|---|
Biotronik SE & Co. KG |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with more than one Significant Serious Adverse Event (SSAE) since home-monitoring activation. SSAE is a composite comprising all-cause mortality, cardiac or device related Serious Adverse Events | 27 months | Yes | |
Secondary | Total costs minimization analyse | 27 months | No | |
Secondary | Delay of Home Monitoring to manage adverse events | 27 months | Yes | |
Secondary | Sensitivity of Home Monitoring to detect ICD dysfunction | 27 months | Yes | |
Secondary | Number of capacitor charge and incidence on ICD-battery longevity | 27 months | No | |
Secondary | Difference of cardiac and device related Adverse Event | 27 Months | Yes |
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