Defibrillators, Tachycardia
Conditions
Keywords
Remote monitoring, Defibrillators, Survey, Indication for ICD (primary and secondary prevention)
Brief summary
Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring implementation.
Detailed description
500 patients with an indication for ICD (primary and secondary prevention) will be included in the registry during a period of 12 months. For the survey, patients must answer two questionnaires. The first one will assess the knowledges regarding Home-Monitoring which certainly depend on the time devoted to patient information during the implantation. This period of training is important and has a direct impact on the CardioMessenger use by the patient. Although the study is multicenter, the aim is not to evaluate or compare practices of each center for the information provided to patients. The objective is to find ways to improve this phase. A second questionnaire was designed to observe the perception of Home-monitoring by the patient and thus to understand how this new technology is apprehended. This part is important because we must take in consideration patient point of view and expectations to improve care and offer new products or services. A focus on patients' perception and appreciation may give a support to the elaboration of training and prevention strategies, the anticipation of the needs, and the improvement of the technology. All these improvements may eventually take part in the success of ICD treatment.
Interventions
OTHERRemote monitoring by Home Monitoring system
Standard of care completed with remote monitoring for ICD patients follow-up
Sponsors
Biotronik SE & Co. KG
Biotronik France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primo ICD implantation with Home-Monitoring system
Exclusion criteria
* NYHA Class IV * Pregnant women or women who plan to become pregnant during the trial * Patient whose medical situation is not stable * Presence of psychiatric illness, depression, anxiety disorders * 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 the CardioMessenger correctly * The patient is not willing and able to comply with the protocol (i.e. unable to answer to the questionnaires) * Change of residence expected during the study * Participation in another clinical study * Patient unwilling to sign patient informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 1 month: evaluation of centers training, knowledges and constraints of Home Monitoring implementation. At 6 months follow-up: observe and describe the behavior, the perception, the fears and the appreciation degree linked to this new technology | 6 months |
Countries
France
Outcome results
None listed