Overview

This trial is active, not recruiting.

Conditions icd, sudden cardiac death, ventricular fibrillation, atrial fibrillation, ventricular tachycardia
Sponsor Biotronik SE & Co. KG
Start date March 2012
End date September 2013
Trial size 1750 participants
Trial identifier NCT01594112, HS056

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patient with ICD who received at least one inappropriate diagnosis (with or without therapy) during the 15 months follow-up.

Primary Outcomes

Measure
Relative proportion of patients experiencing at least one inappropriate therapy (retrospective part) or more than one inappropriate therapy (prospective part)
time frame: 15 months

Secondary Outcomes

Measure
Number of diagnoses per patient per year and relative proportion of patients with at least one diagnosis
time frame: 15 months
Relative proportion of patients with a second day of ID
time frame: 15 months
Number of Asymptomatic Inappropriate therapy and Inappropriate therapy without diagnosis
time frame: 15 months
Time to the first ID
time frame: 15 months
Medical reaction time to the ID
time frame: 15 months
Number of days of recurrence within the medical reaction time
time frame: 15 months
Effectiveness of the corrective action and analysis according to the initial ID type
time frame: 15 months
Classification of ID
time frame: 15 months
Total number of hospitalizations/deaths related to ID and IT
time frame: 15 months
Risk of all-cause mortality
time frame: 15 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Inappropriate Therapies and Home Monitoring® in Implantable Cardioverter Defibrillators (ICD)
Principal investigator Jean-Claude DEHARO, Pr. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Biotronik SE & Co. KG.