- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00989417
Benefits of Implantable Cardioverter Defibrillator Follow-up Using Remote Monitoring (ECOST)
Effectiveness and Cost Of ICD Follow-up Schedule With Telecardiology
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
State-of-the-art implantable cardioverter defibrillators (ICD) provide a variety of algorithms to optimize episode classification and to minimize the danger of delivering inadequate therapies. An important role in checking the correctness of episode detection, classification and treatment plays the intracardiac electrogram (IEGM), which is stored inside the ICD for every detected episode. However, to analyze the stored IEGM, the physician has to interrogate the implant, i.e. the patient has to visit the ICD ambulance for follow-up. As a result, follow-ups are performed principally to corroborate that the ICD has correctly classified and treated detected tachycardia episodes, to optimize the parameters and in case of adverse event detection, to modify the programmation.
The extension of BIOTRONIK Home Monitoring® by IEGM-Online® with LUMOS ICD offers a new possibility to meet the following challenge:
Due to its integrated long-distance telemetry, the implantable cardioverter defibrillator (ICD) LUMOS is capable of periodically transmitting data and IEGM-online from the ICD memory to the BIOTRONIK Service Center via patient device. The BIOTRONIK Service Center decodes the data and presents it to the physician on a password secured internet site. Additionally, in case certain event criteria are met, the most important Home Monitoring information is immediately faxed to the physician as an Event Report. These events can be customized by the physician. Thus, the physician will be able to closely monitor the patient and check the adequacy and efficiency of the ICD therapy without requiring the patient to visit the physician. The transmitted data comprise information on atrial and ventricular rhythm, atrioventricular conduction and system status.
The purpose of the present study is to evaluate the safety and economic impact of ICD follow-up schedule with Home Monitoring in France. For this assessment, the investigation compares two groups: For the ACTIVE group, after a first follow-up, the patients are only followed by Home Monitoring and one follow-up per year. The ICD follow-up or therapeutic intervention will be primarily based and triggered on event reports reception and after cardio reports and IEGM-online analysis on internet site. The findings from this group will be compared to those of a group receiving standard of care (CONTROL group). Both patient groups will be followed for 27 months and will have Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed. The clinical study will analyse, the incidence of significant serious adverse events (composite of all-cause mortality, cardiac and device related SAE), the costs reduction, the home-monitoring workload, the quality of life, the incremental Costs/Effectiveness ratio, the patient willing-to-pay, the delay of Home Monitoring to manage adverse events, the sensitivity of Home Monitoring to detect ICD dysfunctions, the inappropriate therapies rate and impact on hospitalization, the number of ICD charge and impact on battery longevity.
The trial will be conducted as a prospective, randomized, open, multicenter, national clinical trial. The enrolment of 400 patients in 40 clinical centres in France is anticipated
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Lille, Frankreich
- CHRU de Lille- Hôpital Cardiologique
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Indication for single or dual chamber ICD
Exclusion Criteria:
- NYHA class IV
- Pregnant woman or woman who plan to become pregnant during the trial
- Patient whose medical situation is not stable
- 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 Home Monitoring system correctly
- The patient is not willing and able to comply with the protocol
- Change of residence expected during study
- Insufficient GSM coverage at patient's home
- Participation in another clinical study
- Patient unwilling to sign the consent for participation.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: CONTROL Group - Without Home Monitoring
Patients receiving the standard of care.
Due to safety concerns, the patients are followed every 6 months after a first follow-up, which is performed between 1 and 3 months after implantation.
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Both patient groups will be followed for 27 months and will have Home Monitoring switched on.
The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.
|
Experimental: ACTIVE GROUP With Home Monitoring
After a first follow-up (between 1 and 3 months after implantation), the patients are followed one time per year.
Within this period, the additional ICD follow-up or therapeutic intervention will be primarily triggered on cardio-reports reception, Data/IEGM-online analysis on internet site or patient/physician call.
|
Both patient groups will be followed for 27 months and will have Home Monitoring switched on.
The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Number of patients with more than one Significant Serious Adverse Event (SSAE) since home-monitoring activation. SSAE is a composite comprising all-cause mortality, cardiac or device related Serious Adverse Events
Zeitfenster: 27 months
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27 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Total costs minimization analyse
Zeitfenster: 27 months
|
27 months
|
Delay of Home Monitoring to manage adverse events
Zeitfenster: 27 months
|
27 months
|
Sensitivity of Home Monitoring to detect ICD dysfunction
Zeitfenster: 27 months
|
27 months
|
Number of capacitor charge and incidence on ICD-battery longevity
Zeitfenster: 27 months
|
27 months
|
Difference of cardiac and device related Adverse Event
Zeitfenster: 27 Months
|
27 Months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Salem S KACET, Prof. Dr., CHRU de Lille- Hôpital Cardiologique - F 59037Lille -FRANCE
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Kacet S; ECOST trial Investigators. Costs of remote monitoring vs. ambulatory follow-ups of implanted cardioverter defibrillators in the randomized ECOST study. Europace. 2014 Aug;16(8):1181-8. doi: 10.1093/europace/euu012. Epub 2014 Mar 9.
- Guedon-Moreau L, Kouakam C, Klug D, Marquie C, Brigadeau F, Boule S, Blangy H, Lacroix D, Clementy J, Sadoul N, Kacet S. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial. J Cardiovasc Electrophysiol. 2014 Jul;25(7):763-70. doi: 10.1111/jce.12405. Epub 2014 Apr 10.
- Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S; ECOST trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2013 Feb;34(8):605-14. doi: 10.1093/eurheartj/ehs425. Epub 2012 Dec 13.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FRA041
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