Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2026-03-06 @ 5:56 PM
Study NCT ID:
NCT01594112
Status:
COMPLETED
Last Update Posted:
2017-03-17
First Post:
2012-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
Inappropriate Therapies and Home Monitoring® in Implantable Cardioverter Defibrillators (ICD)
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THORN
Brief Summary:
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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: