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)
1 other identifier
observational
512
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Typical duration for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2012
CompletedFirst Submitted
Initial submission to the registry
May 3, 2012
CompletedFirst Posted
Study publicly available on registry
May 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMarch 17, 2017
March 1, 2017
1.5 years
May 3, 2012
March 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Number of diagnoses per patient per year and relative proportion of patients with at least one diagnosis
15 months
Relative proportion of patients with a second day of ID
15 months
Number of Asymptomatic Inappropriate therapy and Inappropriate therapy without diagnosis
15 months
Time to the first ID
15 months
Medical reaction time to the ID
15 months
- +5 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Population implanted of ICD with Biotronik Home Monitoring® system. 512 patients will be selected by investigators in 50 centers in France.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
CH d'Aix en Provence
Aix-en-Provence, 13100, France
CH d'Angers
Angers, 49033, France
CH d'Avignon
Avignon, 84000, France
CH de la Cote Basque
Bayonne, 64100, France
Clinique Lafourcade
Bayonne, 64100, France
Clinique Saint Augustin
Bordeaux, 33000, France
CHU de Nancy
Bourgogne, 54500, France
CHU la Cavale Blanche
Brest, 29200, France
CH William-Morey
Chalon-sur-Saône, 71100, France
CHG de Chateauroux
Châteauroux, 36000, France
Hôpital Militaire
Clamart, 92140, France
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
Hôpital Albert Schweitzer
Colmar, 68000, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
CH de DAX
Dax, 40100, France
CHU de Dijon
Dijon, 21000, France
CHU Albert Michalon
Grenoble, 38043, France
CH de Haguenau
Haguenau, 67500, France
CH de Lagny sur Marne
Lagny-sur-Marne, 77400, France
CH Robert Boulin
Libourne, 33500, France
CHRU de Lille
Lille, 59000, France
CH St Luc St Joseph
Lyon, 69007, France
Clinique de la Sauvegarde
Lyon, 69338, France
Hôpital Cardiologique
Lyon, 69394, France
Hôpital Nord
Marseille, 13015, France
Hôpital La Timone
Marseille, 13385, France
Institut Jacques Cartier
Massy, 91300, France
CHI de Montfermeil
Montfermeil, 93370, France
CHU de Montpellier
Montpellier, 34295, France
Clinique du Milénaire
Montpellier, 34960, France
CH de Moulins
Moulins, 03006, France
Clinique Ambroise Paré
Nancy, 54100, France
CHU G. & R. Laënnec
Nantes, 44.035, France
CHU Nîmes
Nîmes, 30029, France
Hôpital Georges Pompidou
Paris, 75015, France
CH de Pau
Pau, 64000, France
Clinique Saint Pierre
Perpignan, 66000, France
CHU Bordeaux
Pessac, 33064, France
CH de Périgueux
Périgueux, 24000, France
CHU la Mileterie
Poitiers, 86000, France
CHU (Hôpital Pontchaillou)
Rennes, 35033, France
CH de Rodez
Rodez, 12027, France
Chu Hôpital Charles Nicolle
Rouen, 76031, France
CH de Saint Brieuc
Saint-Brieuc, 22000, France
CHU de St-Etienne
Saint-Etienne, 42055, France
CH d'Angoulême
Saint-Michel, 16470, France
Hôpital Font Pré
Toulon, 83100, France
Clinique Pasteur
Toulouse, 31076, France
CHRU Tours (Hôpital Trousseau)
Tours, 37044, France
Clinique Saint Joseph
Trélazé, 49800, France
CH de Troyes
Troyes, 10003, France
CH de Valence
Valence, 26000, France
CH de Valenciennes
Valenciennes, 59300, France
CH Bretagne Atlantique
Vannes, 56000, France
CH de Villefranche
Villefranche-sur-Saône, 69655, France
Related Publications (1)
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.
PMID: 30605510DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Claude DEHARO, Pr. Dr.
Hôpital La Timone, 264 rue St. Pierre, 13385 MARSEILLE Cedex 5
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2012
First Posted
May 8, 2012
Study Start
March 15, 2012
Primary Completion
September 27, 2013
Study Completion
April 1, 2015
Last Updated
March 17, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share