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

Sponsor

Biotronik SE & Co. KG (Industry)

Overall Status

Completed

CT.gov ID

NCT01594112

Collaborator

(none)

512

Enrollment

Locations

36.5

Actual Duration (Months)

9.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ICD Sudden Cardiac Death Ventricular Fibrillation Atrial Fibrillation Ventricular Tachycardia

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 Design

Study Type:

Observational

Actual Enrollment :

512 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 15, 2012

Actual Primary Completion Date :

Sep 27, 2013

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Relative proportion of patients experiencing at least one inappropriate therapy (retrospective part) or more than one inappropriate therapy (prospective part) [15 months]
Study of the relationship between the detection of ID, the corrective action taken and the recurrence of ID of the same mechanism.

Secondary Outcome Measures

Number of diagnoses per patient per year and relative proportion of patients with at least one diagnosis [15 months]
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.
Relative proportion of patients with a second day of ID [15 months]
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.
Number of Asymptomatic Inappropriate therapy and Inappropriate therapy without diagnosis [15 months]
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.
Time to the first ID [15 months]
The time from the enrolment until the first EGM revealing the ID will be assessed.
Medical reaction time to the ID [15 months]
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).
Number of days of recurrence within the medical reaction time [15 months]
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).
Effectiveness of the corrective action and analysis according to the initial ID type [15 months]
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.
Classification of ID [15 months]
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.
Total number of hospitalizations/deaths related to ID and IT [15 months]
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.
Risk of all-cause mortality [15 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH d'Aix en Provence	Aix en Provence	France	13100
2	CH d'Angers	Angers	France	49033
3	CH d'Avignon	Avignon	France	84000
4	CH de la Cote Basque	Bayonne	France	64100
5	Clinique Lafourcade	Bayonne	France	64100
6	Clinique Saint Augustin	Bordeaux	France	33000
7	CHU de Nancy	Bourgogne	France	54500
8	CHU la Cavale Blanche	Brest	France	29200
9	CH William-Morey	Chalons sur Saone	France	71100
10	CHG de Chateauroux	Chateauroux	France	36000
11	Hôpital Militaire	Clamart	France	92140
12	CHU Clermont-Ferrand	Clermont-Ferrand	France	63003
13	Hôpital Albert Schweitzer	Colmar	France	68000
14	Centre Hospitalier Sud Francilien	Corbeil Essonnes	France	91106
15	CH de DAX	Dax	France	40100
16	CHU de Dijon	Dijon	France	21000
17	CHU Albert Michalon	Grenoble	France	38043
18	CH de Haguenau	Haguenau	France	67500
19	CH de Lagny sur Marne	Lagny-sur-Marne	France	77400
20	CH Robert Boulin	Libourne	France	33500
21	CHRU de Lille	Lille	France	59000
22	CH St Luc St Joseph	Lyon	France	69007
23	Clinique de la Sauvegarde	Lyon	France	69338
24	Hôpital Cardiologique	Lyon	France	69394
25	Hôpital Nord	Marseille	France	13015
26	Hôpital La Timone	Marseille	France	13385
27	Institut Jacques Cartier	Massy	France	91300
28	CHI de Montfermeil	Montfermeil	France	93370
29	CHU de Montpellier	Montpellier	France	34295
30	Clinique du Milénaire	Montpellier	France	34960
31	CH de Moulins	Moulins	France	03006
32	Clinique Ambroise Paré	Nancy	France	54100
33	CHU G. & R. Laënnec	Nantes	France	44.035
34	CHU Nîmes	Nimes	France	30029
35	Hôpital Georges Pompidou	Paris	France	75015
36	CH de Pau	Pau	France	64000
37	CH de Périgueux	Perigueux	France	24000
38	Clinique Saint Pierre	Perpignan	France	66000
39	CHU Bordeaux	Pessac	France	33064
40	CHU la Mileterie	Poitiers	France	86000
41	CHU (Hôpital Pontchaillou)	Rennes	France	35033
42	CH de Rodez	Rodez	France	12027
43	Chu Hôpital Charles Nicolle	Rouen	France	76031
44	CH de Saint Brieuc	Saint Brieuc	France	22000
45	CHU de St-Etienne	Saint Etienne	France	42055
46	CH d'Angoulême	Saint Michel	France	16470
47	Hôpital Font Pré	Toulon	France	83100
48	Clinique Pasteur	Toulouse	France	31076
49	CHRU Tours (Hôpital Trousseau)	Tours	France	37044
50	Clinique Saint Joseph	Trelaze	France	49800
51	CH de Troyes	Troyes	France	10003
52	CH de Valence	Valence	France	26000
53	CH de Valenciennes	Valenciennes	France	59300
54	CH Bretagne Atlantique	Vannes	France	56000
55	CH de Villefranche	Villefranche sur Saone	France	69655