Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators. (THORN)

Biotronik

Status: Completed

Conditions: Atrial Fibrillation; Ventricular Fibrillation; Sudden Cardiac Death; ICD; Ventricular Tachycardia

Study type: Observational

Funder types: Industry

Identifiers

NCT01594112

HS056

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 512 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

512 participants in 1 patient group

Patient with at least one ID

Description:

Patient with ICD who received at least one inappropriate diagnosis (with or without therapy) during the 15 months follow-up.