Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
The purpose of the THORN registry is to show the ability of Home-Monitoring® to early
 identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients
 (i.e. lead rupture, atrial arrhythmia, oversensing…) whatever the type of device (single,
 dual, or triple chamber).

 The electromyograms (iEGMs) provided by Remote Patient Monitoring will help the physician to
 early detect inadequate arrhythmia detection (ID) that can be responsible for inappropriate
 therapies (IT), and to take preventive actions in order to reduce the burden of these
 inappropriate therapies.

 THORN is an observational epidemiologic, prospective and multicenter registry. The primary
 objective is to measure the relative proportion of patients experiencing at least one
 inappropriate therapy during a fifteen months follow-up period. Moreover, THORN will assess
 the incidence, predictors, outcome and recurrence of inappropriate diagnoses in 1750 ICD
 patients.
Remote Patient Monitoring allows early detection of events that can generate inadequate
 detection of ventricular arrhythmia (i.e. lead rupture, atrial arrhythmia, oversensing….) and
 be responsible for inappropriate therapies. In such cases, it may be assumed that physicians
 can react earlier and take preventive actions, in order to reduce the risk or burden of
 inappropriate therapies.

 The THORN registry has two purposes:

 -  To determine retrospectively the relative proportion of patients experiencing at least
 one inappropriate therapy during 15-months of follow-up, in ICD patients equipped with
 Home Monitoring®. This part concern 1240 patients.

 -  To evaluate prospectively the relationship between the detection of inappropriate
 diagnosis (with or without subsequent inappropriate therapy), the corrective action
 taken, and the recurrences of inappropriate diagnosis of the same origin/mechanism. This
 part concerns 510 patients.

 BIOTRONIK Home Monitoring® by iEGM-Online® with Biotronik ICD devices (LUMAX) systematically
 stores any episode classified as ventricular tachycardia (VT) or ventricular fibrillation
 (VF) which is transmitted to the physician.

 In the THORN study, in addition to the physicians' analysis, all electromyograms will be
 reviewed by an adjudication committee in order to classify them as appropriate or
 inappropriate diagnosis.
Inclusion Criteria:

 -  Subject implanted with a single, dual, or triple chambers ICD within the last 3 months

 -  Home Monitoring® activated and functional since hospital discharge

 -  Patient willing and able to comply with the protocol and who has provided written
 informed consent about Home Monitoring®,

 -  Patient whose medical situation is stable

 Exclusion Criteria:

 -  ICD replacements

 -  New York Heart Association Function Class IV patients

 -  Pregnant women or women who plan to become pregnant during the trial

 -  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 Biotronik's transmitter correctly

 -  Change of residence expected during the study

 -  Insufficient global system for mobile communication (GSM) coverage at patient's home

 -  Participation in another clinical study