Ventricular Fibrillation Clinical Trial
Official 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.
State-of-the-art implantable cardioverter defibrillators (ICD) provide a variety of
algorithms to optimize episode classification and to minimize the danger of delivering
inadequate therapies. An important role in checking the correctness of episode detection,
classification and treatment plays the intracardiac electrogram (IEGM), which is stored
inside the ICD for every detected episode. However, to analyze the stored IEGM, the
physician has to interrogate the implant, i.e. the patient has to visit the ICD ambulance
for follow-up. As a result, follow-ups are performed principally to corroborate that the ICD
has correctly classified and treated detected tachycardia episodes, to optimize the
parameters and in case of adverse event detection, to modify the programmation.
The extension of BIOTRONIK Home Monitoring® by IEGM-Online® with LUMOS ICD offers a new
possibility to meet the following challenge:
Due to its integrated long-distance telemetry, the implantable cardioverter defibrillator
(ICD) LUMOS is capable of periodically transmitting data and IEGM-online from the ICD memory
to the BIOTRONIK Service Center via patient device. The BIOTRONIK Service Center decodes the
data and presents it to the physician on a password secured internet site. Additionally, in
case certain event criteria are met, the most important Home Monitoring information is
immediately faxed to the physician as an Event Report. These events can be customized by the
physician. Thus, the physician will be able to closely monitor the patient and check the
adequacy and efficiency of the ICD therapy without requiring the patient to visit the
physician. The transmitted data comprise information on atrial and ventricular rhythm,
atrioventricular conduction and system status.
The purpose of the present study is to evaluate the safety and economic impact of ICD
follow-up schedule with Home Monitoring in France. For this assessment, the investigation
compares two groups: For the ACTIVE group, after a first follow-up, the patients are only
followed by Home Monitoring and one follow-up per year. The ICD follow-up or therapeutic
intervention will be primarily based and triggered on event reports reception and after
cardio reports and IEGM-online analysis on internet site. The findings from this group will
be compared to those of a group receiving standard of care (CONTROL group). Both patient
groups will be followed for 27 months and will have Home Monitoring switched on. The data
from the CONTROL group will not be presented online to the attending physician, but a
retrospective analysis on differences between the two groups will be performed. The clinical
study will analyse, the incidence of significant serious adverse events (composite of
all-cause mortality, cardiac and device related SAE), the costs reduction, the
home-monitoring workload, the quality of life, the incremental Costs/Effectiveness ratio,
the patient willing-to-pay, the delay of Home Monitoring to manage adverse events, the
sensitivity of Home Monitoring to detect ICD dysfunctions, the inappropriate therapies rate
and impact on hospitalization, the number of ICD charge and impact on battery longevity.
The trial will be conducted as a prospective, randomized, open, multicenter, national
clinical trial. The enrolment of 400 patients in 40 clinical centres in France is
anticipated
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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