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

NCT ID: NCT01594112

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 512 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-15
• Study Completion Date: 2015-04-01

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.

Conditions

ICD; Sudden Cardiac Death; Ventricular Fibrillation; Atrial Fibrillation; Ventricular Tachycardia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Claude DEHARO, Pr. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hôpital La Timone, 264 rue St. Pierre, 13385 MARSEILLE Cedex 5

Locations

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

Chalon-sur-Saône, , France

CHG de Chateauroux

Châteauroux, , 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 Nord

Marseille, , France

Hôpital La Timone

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

Nîmes, , France

Hôpital Georges Pompidou

Paris, , France

CH de Pau

Pau, , France

Clinique Saint Pierre

Perpignan, , France

CHU Bordeaux

Pessac, , France

CH de Périgueux

Périgueux, , 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

Trélazé, , 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-Saône, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 30605510 (View on PubMed)

Other Identifiers

HS056

Identifier Type: -

Identifier Source: org_study_id