Clinical trial NCT01594112: Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
Official title: Inappropriate Therapies and Home Monitoring® in Implantable Cardioverter Defibrillators (ICD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICD
Sudden Cardiac Death
Ventricular Fibrillation
Atrial Fibrillation
Ventricular Tachycardia
Keywords: Remote monitoring
Home monitoring
Defibrillators, Implantable cardioverter-defibrillator
Shock
Inappropriate diagnoses and Therapies
Corrective actions
ID recurrences
Medical reaction time
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population implanted of ICD with Biotronik Home Monitoring® system. 512 patients will be selected by investigators in 50 centers in France.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative proportion of patients experiencing at least one inappropriate therapy (retrospective part) or more than one inappropriate therapy (prospective part)
timeFrame: 15 months
Secondary outcomes:
measure: Number of diagnoses per patient per year and relative proportion of patients with at least one diagnosis
timeFrame: 15 months
measure: Relative proportion of patients with a second day of ID
timeFrame: 15 months
measure: Number of Asymptomatic Inappropriate therapy and Inappropriate therapy without diagnosis
timeFrame: 15 months
measure: Time to the first ID
timeFrame: 15 months
measure: Medical reaction time to the ID
timeFrame: 15 months
measure: Number of days of recurrence within the medical reaction time
timeFrame: 15 months
measure: Effectiveness of the corrective action and analysis according to the initial ID type
timeFrame: 15 months
measure: Classification of ID
timeFrame: 15 months
measure: Total number of hospitalizations/deaths related to ID and IT
timeFrame: 15 months
measure: Risk of all-cause mortality
timeFrame: 15 months
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: CH d'Aix en Provence
city: Angers
country: France
facility: CH d'Angers
city: Avignon
country: France
facility: CH d'Avignon
city: Bayonne
country: France
facility: CH de la Cote Basque
city: Bayonne
country: France
facility: Clinique Lafourcade
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Bourgogne
country: France
facility: CHU de Nancy
city: Brest
country: France
facility: CHU la Cavale Blanche
city: Chalons sur Saone
country: France
facility: CH William-Morey
city: Chateauroux
country: France
facility: CHG de Chateauroux
city: Clamart
country: France
facility: Hôpital Militaire
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Colmar
country: France
facility: Hôpital Albert Schweitzer
city: Corbeil Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Dax
country: France
facility: CH de DAX
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU Albert Michalon
city: Haguenau
country: France
facility: CH de Haguenau
city: Lagny-sur-Marne
country: France
facility: CH de Lagny sur Marne
city: Libourne
country: France
facility: CH Robert Boulin
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: CH St Luc St Joseph
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Lyon
country: France
facility: Hôpital Cardiologique
city: Marseille
country: France
facility: Hôpital Nord
city: Marseille
country: France
facility: Hôpital La Timone
city: Massy
country: France
facility: Institut Jacques Cartier
city: Montfermeil
country: France
facility: CHI de Montfermeil
city: Montpellier
country: France
facility: CHU de Montpellier
city: Montpellier
country: France
facility: Clinique du Milénaire
city: Moulins
country: France
facility: CH de Moulins
city: Nancy
country: France
facility: Clinique Ambroise Paré
city: Nantes
country: France
facility: CHU G. & R. Laënnec
city: Nimes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: Hôpital Georges Pompidou
city: Pau
country: France
facility: CH de Pau
city: Perigueux
country: France
facility: CH de Périgueux
city: Perpignan
country: France
facility: Clinique Saint Pierre
city: Pessac
country: France
facility: CHU Bordeaux
city: Poitiers
country: France
facility: CHU la Mileterie
city: Rennes
country: France
facility: CHU (Hôpital Pontchaillou)
city: Rodez
country: France
facility: CH de Rodez
city: Rouen
country: France
facility: Chu Hôpital Charles Nicolle
city: Saint Brieuc
country: France
facility: CH de Saint Brieuc
city: Saint Etienne
country: France
facility: CHU de St-Etienne
city: Saint Michel
country: France
facility: CH d'Angoulême
city: Toulon
country: France
facility: Hôpital Font Pré
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHRU Tours (Hôpital Trousseau)
city: Trelaze
country: France
facility: Clinique Saint Joseph
city: Troyes
country: France
facility: CH de Troyes
city: Valence
country: France
facility: CH de Valence
city: Valenciennes
country: France
facility: CH de Valenciennes
city: Vannes
country: France
facility: CH Bretagne Atlantique
city: Villefranche sur Saone
country: France
facility: CH de Villefranche
Study officials:
affiliation: Hôpital La Timone, 264 rue St. Pierre, 13385 MARSEILLE Cedex 5
name: Jean-Claude DEHARO, Pr. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perrin T, Boveda S, Defaye P, Rosier A, Sadoul N, Bordachar P, Klug D, Ritter P, Belhameche M, Babuty D, Mansourati J, Lazarus A, Deharo JC. Role of medical reaction in management of inappropriate ventricular arrhythmia diagnosis: the inappropriate Therapy and HOme monitoRiNg (THORN) registry. Europace. 2019 Apr 1;21(4):607-615. doi: 10.1093/europace/euy284.