Implantable Cardioverter-DefibrillatorsECOSTNCT00989417
Benefits of Implantable Cardioverter Defibrillator Follow-up Using Remote Monitoring
A study testing ACTIVATION of HOME MONITORING in people with Implantable Cardioverter-Defibrillators and Ventricular Fibrillation, run by Biotronik SE & Co. KG at 1 site in France.
Trial summary
In many aspects of every-day life, modern communication systems bring about a remarkable increase in comfort and safety by transmitting data and information in an easy and reliable manner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Cardioverter-Defibrillators, Ventricular Fibrillation, Tachycardia, Ventricular
- What is being tested?
- ACTIVATION of HOME MONITORING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Oct 2010
- Phase
- Interventional
- 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
Who may be able to join
- Indication for single or dual chamber ICD
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Cost Of ICD Follow-up Schedule With Telecardiology
In many aspects of every-day life, modern communication systems bring about a remarkable increase in comfort and safety by transmitting data and information in an easy and reliable manner. In order to provide these advantages also to patients with implantable cardioverter-defibrillators, as well as to their physicians, BIOTRONIK has developed a long-distance implant telemetry to enable periodic trend and event-triggered transmissions of implant data and intracardiac electrogram over distances of several meters. The data is received by a patient device and subsequently automatically transferred to a BIOTRONIK Service Center that provides it to the physician on a password secured internet site. Hence, the physician receives diagnostic information without the patient having to visit the physician (Home Monitoring, HM). New possibilities will arise for a detailed medical and event-correlated supervision of the patient's therapy using electrically active implants.
Read the detailed description
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
- Conditions
- Implantable Cardioverter-Defibrillators, Ventricular Fibrillation, Tachycardia, Ventricular
- Being tested
- ACTIVATION of HOME MONITORING
- Keywords
- Remote monitoring, Defibrillators, Implantable, Home monitoring, Shock, Implantable cardioverter-defibrillator Therapy
- Medical subject headings
- Ventricular Fibrillation, Tachycardia, Ventricular, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVATION of HOME MONITORINGOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL Group - Without Home Monitoring | Active comparator | 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. Receives: Other: ACTIVATION of HOME MONITORING |
| ACTIVE GROUP With Home Monitoring | Experimental | 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. Receives: Other: ACTIVATION of HOME MONITORING |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 27 months
Secondary outcomes (5)
Total costs minimization analyse
Measured: 27 months
Delay of Home Monitoring to manage adverse events
Measured: 27 months
Sensitivity of Home Monitoring to detect ICD dysfunction
Measured: 27 months
Number of capacitor charge and incidence on ICD-battery longevity
Measured: 27 months
Difference of cardiac and device related Adverse Event
Measured: 27 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startJan 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Implantable Cardioverter-DefibrillatorsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Salem S KACET, Prof. Dr., Principal investigator, CHRU de Lille- Hôpital Cardiologique - F 59037Lille -FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989417
- Sponsor's protocol ID
- FRA041
- Acronym
- ECOST
- Status last verified
- May 2011
- First submitted
- 2 Oct 2009
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24614572Guedon-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.
PubMed 24602062Guedon-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.
PubMed 23242192
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost Of ICD Follow-up Schedule With Telecardiology
- ClinicalTrials.gov ID
- NCT00989417
- Acronym / sponsor ID
- ECOST / FRA041
- Conditions
- Implantable Cardioverter-Defibrillators, Ventricular Fibrillation, Tachycardia, Ventricular
- Keywords
- Remote monitoring, Defibrillators, Implantable, Home monitoring, Shock, Implantable cardioverter-defibrillator Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 Oct 2009 (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.
In many aspects of every-day life, modern communication systems bring about a remarkable increase in comfort and safety by transmitting data and information in an easy and reliable manner. In order to provide these advantages also to patients with implantable cardioverter-defibrillators, as well as to their physicians, BIOTRONIK has developed a long-distance implant telemetry to enable periodic trend and event-triggered transmissions of implant data and intracardiac electrogram over distances of several meters. The data is received by a patient device and subsequently automatically transferred to a BIOTRONIK Service Center that provides it to the physician on a password secured internet site. Hence, the physician receives diagnostic information without the patient having to visit the physician (Home Monitoring, HM). New possibilities will arise for a detailed medical and event-correlated supervision of the patient's therapy using electrically active implants.
Detailed description
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL Group - Without Home Monitoring | Active comparator | Other: ACTIVATION of HOME MONITORINGPatients 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. |
| ACTIVE GROUP With Home Monitoring | Experimental | Other: ACTIVATION of HOME MONITORINGAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for single or dual chamber ICD
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTIVATION of HOME MONITORINGBoth 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. | Other | ACTIVE GROUP With Home Monitoring, CONTROL Group - Without Home Monitoring |
Primary outcome
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
Time frame: 27 months
5 secondary outcomes
Total costs minimization analyse
Time frame: 27 months
Delay of Home Monitoring to manage adverse events
Time frame: 27 months
Sensitivity of Home Monitoring to detect ICD dysfunction
Time frame: 27 months
Number of capacitor charge and incidence on ICD-battery longevity
Time frame: 27 months
Difference of cardiac and device related Adverse Event
Time frame: 27 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 25 May 2011.
- Derived from this study: PubMed 24614572Guedon-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.
- Derived from this study: PubMed 24602062Guedon-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.
- Derived from this study: PubMed 23242192Guedon-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.
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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.
Salem S KACET, Prof. Dr. principal investigator
CHRU de Lille- Hôpital Cardiologique - F 59037Lille -FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIVATION of HOME MONITORING in people with Implantable Cardioverter-Defibrillators and Ventricular Fibrillation, run by Biotronik SE & Co. KG at 1 site 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 1 inclusion and 11 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 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 (time frame: 27 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 NCT00989417, which also lists 3 linked publications.
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 25 May 2011; AzTrials last refreshed its copy on 8 Nov 2026.