ICDTHORNNCT01594112
Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
An observational study of ICD and Sudden Cardiac Death, run by Biotronik SE & Co. KG at 55 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICD, Sudden Cardiac Death, Ventricular Fibrillation
- How many people
- 512 participants
- Where
- 55 sitesFrance
- Study dates
- 15 Mar 2012to 1 Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population implanted of ICD with Biotronik Home Monitoring® system. 512 patients will be selected by investigators in 50 centers in France.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Change of residence expected during the study
- Insufficient global system for mobile communication (GSM) coverage at patient's home
- Participation in another clinical study
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
France55 sites
CH d'Aix en Provence
Aix-en-Provence, 13100
CH d'Angers
Angers, 49033
CH d'Avignon
Avignon, 84000
CH de la Cote Basque
Bayonne, 64100
Clinique Lafourcade
Bayonne, 64100
Clinique Saint Augustin
Bordeaux, 33000
CHU de Nancy
Bourgogne, 54500
CHU la Cavale Blanche
Brest, 29200
CH William-Morey
Chalon-sur-Saône, 71100
CHG de Chateauroux
Châteauroux, 36000
Hôpital Militaire
Clamart, 92140
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Hôpital Albert Schweitzer
Colmar, 68000
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
CH de DAX
Dax, 40100
CHU de Dijon
Dijon, 21000
CHU Albert Michalon
Grenoble, 38043
CH de Haguenau
Haguenau, 67500
CH de Lagny sur Marne
Lagny-sur-Marne, 77400
CH Robert Boulin
Libourne, 33500
CHRU de Lille
Lille, 59000
CH St Luc St Joseph
Lyon, 69007
Clinique de la Sauvegarde
Lyon, 69338
Hôpital Cardiologique
Lyon, 69394
Hôpital Nord
Marseille, 13015
Hôpital La Timone
Marseille, 13385
Institut Jacques Cartier
Massy, 91300
CHI de Montfermeil
Montfermeil, 93370
CHU de Montpellier
Montpellier, 34295
Clinique du Milénaire
Montpellier, 34960
CH de Moulins
Moulins, 03006
Clinique Ambroise Paré
Nancy, 54100
CHU G. & R. Laënnec
Nantes, 44.035
CHU Nîmes
Nîmes, 30029
Hôpital Georges Pompidou
Paris, 75015
CH de Pau
Pau, 64000
CH de Périgueux
Périgueux, 24000
Clinique Saint Pierre
Perpignan, 66000
CHU Bordeaux
Pessac, 33064
CHU la Mileterie
Poitiers, 86000
CHU (Hôpital Pontchaillou)
Rennes, 35033
CH de Rodez
Rodez, 12027
Chu Hôpital Charles Nicolle
Rouen, 76031
CH de Saint Brieuc
Saint-Brieuc, 22000
CHU de St-Etienne
Saint-Etienne, 42055
CH d'Angoulême
Saint-Michel, 16470
Hôpital Font Pré
Toulon, 83100
Clinique Pasteur
Toulouse, 31076
CHRU Tours (Hôpital Trousseau)
Tours, 37044
Clinique Saint Joseph
Trélazé, 49800
CH de Troyes
Troyes, 10003
CH de Valence
Valence, 26000
CH de Valenciennes
Valenciennes, 59300
CH Bretagne Atlantique
Vannes, 56000
CH de Villefranche
Villefranche-sur-Saône, 69655
About this study
Official title: 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.
Read the 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
- Keywords
- Remote monitoring, Home monitoring, Defibrillators, Implantable cardioverter-defibrillator, Shock, Inappropriate diagnoses and Therapies, Corrective actions, ID recurrences, Medical reaction time
- Medical subject headings
- Death, Sudden, Cardiac, Ventricular Fibrillation, Atrial Fibrillation, Tachycardia, Ventricular, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (10)
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.
Measured: 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.
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.
Measured: 15 months
Time to the first ID
The time from the enrolment until the first EGM revealing the ID will be assessed.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study start15 Mar 2012
- Primary completion27 Sep 2013
- Study completion1 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ICDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Claude DEHARO, Pr. Dr., Principal investigator, Hôpital La Timone, 264 rue St. Pierre, 13385 MARSEILLE Cedex 5
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594112
- Sponsor's protocol ID
- HS056
- Acronym
- THORN
- Status last verified
- Mar 2017
- First submitted
- 3 May 2012
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30605510
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inappropriate Therapies and Home Monitoring® in Implantable Cardioverter Defibrillators (ICD)
- ClinicalTrials.gov ID
- NCT01594112
- Acronym / sponsor ID
- THORN / HS056
- Conditions
- ICD, Sudden Cardiac Death, Ventricular Fibrillation, Atrial Fibrillation, Ventricular Tachycardia
- Keywords
- Remote monitoring, Home monitoring, Defibrillators, Implantable cardioverter-defibrillator, Shock, Inappropriate diagnoses and Therapies, Corrective actions, ID recurrences, Medical reaction time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2012 (actual)
- Primary completion
- 27 Sep 2013 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population implanted of ICD with Biotronik Home Monitoring® system. 512 patients will be selected by investigators in 50 centers in France.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relative proportion of patients experiencing at least one inappropriate therapy (retrospective part) or more than one inappropriate therapy (prospective part)
Time frame: 15 months
Study of the relationship between the detection of ID, the corrective action taken and the recurrence of ID of the same mechanism.
10 secondary outcomes
Number of diagnoses per patient per year and relative proportion of patients with at least one diagnosis
Time frame: 15 months
Relative proportion of patients with a second day of ID
Time frame: 15 months
Number of Asymptomatic Inappropriate therapy and Inappropriate therapy without diagnosis
Time frame: 15 months
Time to the first ID
Time frame: 15 months
Medical reaction time to the ID
Time frame: 15 months
Number of days of recurrence within the medical reaction time
Time frame: 15 months
Effectiveness of the corrective action and analysis according to the initial ID type
Time frame: 15 months
Classification of ID
Time frame: 15 months
Total number of hospitalizations/deaths related to ID and IT
Time frame: 15 months
Risk of all-cause mortality
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Derived from this study: PubMed 30605510Perrin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Claude DEHARO, Pr. Dr. principal investigator
Hôpital La Timone, 264 rue St. Pierre, 13385 MARSEILLE Cedex 5
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICD and Sudden Cardiac Death, run by Biotronik SE & Co. KG at 55 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative proportion of patients experiencing at least one inappropriate therapy (retrospective part) or more than one inappropriate therapy (prospective part) (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01594112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.