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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01594112
Other study ID # HS056
Secondary ID
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
Health authority
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

Study Design


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
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