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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Ventricular Fibrillation; Ventricular Tachycardia; Sudden Cardiac Death; ICD

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.

• Study Type: Observational
• Enrollment (Actual): 512

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13100
    • Ch D'Aix En Provence
  • Angers, France, 49033
    • CH d'Angers
  • Avignon, France, 84000
    • CH d'Avignon
  • Bayonne, France, 64100
    • Clinique Lafourcade
  • Bayonne, France, 64100
    • CH de la Cote Basque
  • Bordeaux, France, 33000
    • Clinique Saint Augustin
  • Bourgogne, France, 54500
    • Chu de Nancy
  • Brest, France, 29200
    • CHU La Cavale Blanche
  • Chalons sur Saone, France, 71100
    • CH William-Morey
  • Chateauroux, France, 36000
    • CHG de Chateauroux
  • Clamart, France, 92140
    • Hopital Militaire
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand
  • Colmar, France, 68000
    • Hôpital Albert Schweitzer
  • Corbeil Essonnes, France, 91106
    • Centre Hospitalier Sud Francilien
  • Dax, France, 40100
    • CH de Dax
  • Dijon, France, 21000
    • CHU de Dijon
  • Grenoble, France, 38043
    • CHU Albert Michalon
  • Haguenau, France, 67500
    • Ch de Haguenau
  • Lagny-sur-Marne, France, 77400
    • CH de Lagny sur Marne
  • Libourne, France, 33500
    • CH Robert Boulin
  • Lille, France, 59000
    • CHRU de Lille
  • Lyon, France, 69007
    • CH St Luc St Joseph
  • Lyon, France, 69338
    • Clinique de la Sauvegarde
  • Lyon, France, 69394
    • Hopital Cardiologique
  • Marseille, France, 13015
    • Hopital Nord
  • Marseille, France, 13385
    • Hôpital La Timone
  • Massy, France, 91300
    • Institut Jacques Cartier
  • Montfermeil, France, 93370
    • CHI de Montfermeil
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Montpellier, France, 34960
    • Clinique du Milénaire
  • Moulins, France, 03006
    • CH de Moulins
  • Nancy, France, 54100
    • Clinique Ambroise Paré
  • Nantes, France, 44.035
    • CHU G. & R. Laënnec
  • Nimes, France, 30029
    • CHU Nîmes
  • Paris, France, 75015
    • Hopital Georges Pompidou
  • Pau, France, 64000
    • CH de Pau
  • Perigueux, France, 24000
    • CH de Périgueux
  • Perpignan, France, 66000
    • Clinique Saint Pierre
  • Pessac, France, 33064
    • CHU Bordeaux
  • Poitiers, France, 86000
    • CHU La Mileterie
  • Rennes, France, 35033
    • CHU (Hôpital Pontchaillou)
  • Rodez, France, 12027
    • CH de Rodez
  • Rouen, France, 76031
    • CHU Hôpital Charles Nicolle
  • Saint Brieuc, France, 22000
    • CH de Saint Brieuc
  • Saint Etienne, France, 42055
    • CHU de St-Etienne
  • Saint Michel, France, 16470
    • CH D'Angouleme
  • Toulon, France, 83100
    • Hopital Font Pré
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Tours, France, 37044
    • CHRU Tours (Hôpital Trousseau)
  • Trelaze, France, 49800
    • Clinique Saint Joseph
  • Troyes, France, 10003
    • CH de Troyes
  • Valence, France, 26000
    • CH de Valence
  • Valenciennes, France, 59300
    • CH de Valenciennes
  • Vannes, France, 56000
    • CH Bretagne Atlantique
  • Villefranche sur Saone, France, 69655
    • CH de Villefranche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Time to the first ID	The time from the enrolment until the first EGM revealing the ID will be assessed.	15 months
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Jean-Claude DEHARO, Pr. Dr., Hôpital La Timone, 264 rue St. Pierre, 13385 MARSEILLE Cedex 5

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2012
• Primary Completion (Actual): September 27, 2013
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Shock; Remote monitoring; Home monitoring; Defibrillators, Implantable cardioverter-defibrillator; Inappropriate diagnoses and Therapies; Corrective actions; ID recurrences; Medical reaction time
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Arrest; Death; Atrial Fibrillation; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Death, Sudden, Cardiac
• Other Study ID Numbers: HS056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No