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

Atrial Fibrillation Clinical Trial

— THORN  

Official title:

Inappropriate Therapies and Home Monitoring® in Implantable Cardioverter Defibrillators (ICD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594112
• Other study ID #: HS056
• Status: Completed
• Phase: N/A
• First received: May 3, 2012
• Last updated: March 16, 2017
• Start date: March 15, 2012
• Est. completion date: April 1, 2015

Study information

• Verified date: March 2017
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: April 1, 2015
• Est. primary completion date: September 27, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Death
• Death, Sudden, Cardiac
• ICD
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Locations

Country	Name	City	State
France	CH d'Aix en Provence	Aix en Provence
France	CH d'Angers	Angers
France	CH d'Avignon	Avignon
France	CH de la Cote Basque	Bayonne
France	Clinique Lafourcade	Bayonne
France	Clinique Saint Augustin	Bordeaux
France	CHU de Nancy	Bourgogne
France	CHU la Cavale Blanche	Brest
France	CH William-Morey	Chalons sur Saone
France	CHG de Chateauroux	Chateauroux
France	Hôpital Militaire	Clamart
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Hôpital Albert Schweitzer	Colmar
France	Centre Hospitalier Sud Francilien	Corbeil Essonnes
France	CH de DAX	Dax
France	CHU de Dijon	Dijon
France	CHU Albert Michalon	Grenoble
France	CH de Haguenau	Haguenau
France	CH de Lagny sur Marne	Lagny-sur-Marne
France	CH Robert Boulin	Libourne
France	CHRU de Lille	Lille
France	CH St Luc St Joseph	Lyon
France	Clinique de la Sauvegarde	Lyon
France	Hôpital Cardiologique	Lyon
France	Hôpital La Timone	Marseille
France	Hôpital Nord	Marseille
France	Institut Jacques Cartier	Massy
France	CHI de Montfermeil	Montfermeil
France	CHU de Montpellier	Montpellier
France	Clinique du Milénaire	Montpellier
France	CH de Moulins	Moulins
France	Clinique Ambroise Paré	Nancy
France	CHU G. & R. Laënnec	Nantes
France	CHU Nîmes	Nimes
France	Hôpital Georges Pompidou	Paris
France	CH de Pau	Pau
France	CH de Périgueux	Perigueux
France	Clinique Saint Pierre	Perpignan
France	CHU Bordeaux	Pessac
France	CHU la Mileterie	Poitiers
France	CHU (Hôpital Pontchaillou)	Rennes
France	CH de Rodez	Rodez
France	Chu Hôpital Charles Nicolle	Rouen
France	CH de Saint Brieuc	Saint Brieuc
France	CHU de St-Etienne	Saint Etienne
France	CH d'Angoulême	Saint Michel
France	Hôpital Font Pré	Toulon
France	Clinique Pasteur	Toulouse
France	CHRU Tours (Hôpital Trousseau)	Tours
France	Clinique Saint Joseph	Trelaze
France	CH de Troyes	Troyes
France	CH de Valence	Valence
France	CH de Valenciennes	Valenciennes
France	CH Bretagne Atlantique	Vannes
France	CH de Villefranche	Villefranche sur Saone

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative proportion of patients experiencing at least one inappropriate therapy (retrospective part) or more than one inappropriate therapy (prospective part)	Study of the relationship between the detection of ID, the corrective action taken and the recurrence of ID of the same mechanism.	15 months
Secondary	Number of diagnoses per patient per year and relative proportion of patients with at least one diagnosis	The number of diagnoses per patient per year and the associated proportion of patients (with at least one diagnosis) will be measured. This will give the incidence rate of experiencing special classes of diagnoses over the 15-months follow-up period. The following subclasses will be assessed: Appropriate or not diagnoses, ID without therapy, therapies defined as shocks or antitachycardia pacing (ATP), shocks, inappropriate shocks, recurrence of ID and recurrence of inappropriate shocks.; The prospective part will be compared to the retrospective part.	15 months
Secondary	Relative proportion of patients with a second day of ID	Knowing that the intervals between ID days cannot be predetermined (non normal distribution), medical reaction time anticipated with Home Monitoring® can reduce the number of patients with a second day of ID.; The proportion of patients with more than one inappropriate diagnosis will be measured.	15 months
Secondary	Number of Asymptomatic Inappropriate therapy and Inappropriate therapy without diagnosis	Knowing that the main added value of Home Monitoring® relates on asymptomatic inappropriate therapies and inappropriate diagnoses without therapy (IDWT), the number of asymptomatic IT or IDWT patient per year and the associated proportion of patients (with at least one inappropriate diagnosis) will be measured.	15 months
Secondary	Time to the first ID	The time from the enrolment until the first EGM revealing the ID will be assessed.	15 months
Secondary	Medical reaction time to the ID	The time from the first ID to the follow-up visit during which a corrective action is taken is defined as the medical reaction time and will be assessed.; In case of hospitalization without a follow-up visit (lead replacement for instance), the first day of hospitalization will be considered as the follow-up visit date.; In current practice, the patients receiving shocks are advised to call their physicians in order to have their ICD interrogated. The analysis will distinguish the symptomatic IT and the asymptomatic ID (asymptomatic IT or IDWT).	15 months
Secondary	Number of days of recurrence within the medical reaction time	The number of days with at least one ID within the medical reaction time is defined as the number of days of recurrence and will be evaluated with the associated proportion of patients. The analysis will distinguish the symptomatic IT and the asymptomatic ID (asymptomatic IT or IDWT).	15 months
Secondary	Effectiveness of the corrective action and analysis according to the initial ID type	The proportion of patients with at least one inappropriate diagnosis recurrence (first day of recurrence) after the corrective action, and with the same ID mechanism as the original one, will be evaluated.; A subgroup analysis depending on the ID mechanism will be performed, considering the inhomogeneous efficiency of the corrective action depending on the initial mechanism of the inappropriate diagnosis/therapy .; The time from the follow-up visit during which the corrective action is taken until the next ID will be measured to assess the effectiveness of the corrective action.	15 months
Secondary	Classification of ID	The proportion of patient in the following classes of ID episodes will be evaluated: Atrial fibrillation,; Other forms of supraventricular tachyarrhythmia; Sinus tachycardia; Abnormal sensing (T wave oversensing, interferences,…); Other: the comparison is performed as an inter observer comparison between the Adjudication Board's and the physician's classification.	15 months
Secondary	Total number of hospitalizations/deaths related to ID and IT	Knowing that inappropriate therapies are among the heaviest ICD side-effects, the total number of hospitalizations and deaths related to ID or IT will be assessed.	15 months
Secondary	Risk of all-cause mortality	The risk of death associated with inappropriate therapy only, with the inappropriate shocks only, with any shocks, without any therapy, without any shocks will be evaluated.	15 months