Defibrillators, ImplantableEVATELNCT00598026
Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
A study testing Tele- follow-up and Conventional follow-up in people with Defibrillators, Implantable and Telemedicine, run by Rennes University Hospital at 30 sites in France.
Trial summary
The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Defibrillators, Implantable, Telemedicine
- What is being tested?
- Tele- follow-up and Conventional follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,501 participants
- Where
- 30 sitesFrance
- Study dates
- 14 Jan 2008to 7 Mar 2011
- 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
- Adults over 18,
- First implantation of an implantable cardioverter defibrillator device (CRT-D devices being excluded), single or dual-chamber in primary or secondary prevention,
- ICD with data-transmission features,
- GSM mobile phone network at patient home compatible with remote transmission,
- Patient able to use correctly the transmission system,
- Patients having given a written informed consent.
Who cannot join
- Class IV of NYHA,
- Concomitant pathology leading to a life expectancy inferior to the protocol duration,
- Concomitant participation to another protocol.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
France30 sites
Service de Cardiologie - Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13100
Service de Cardiologie - CHU d'Angers
Angers, 49033
Service de Cardiologie - CHU Jean Minjoz
Besançon, 25000
Service de Cardiologie -Hôpital de la Cavale Blanche
Brest, 29609
Service de Cardiologie - Groupement Hospitalier Est de Lyon
Bron, 69677
Service de Cardiologie - Hôpital de la Côte de Nacre
Caen, 14000
Service de Cardiologie - CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Service de Cardiologie - Hôpital Henri Mondor
Créteil
Centre de Cardiologie - CHU de Dijon
Dijon, 21000
Service de cardiologie et Urgences cardiologiques - Hôpital Michallon
Grenoble, 38043
Cardiologie A - CHRU de Lille
Lille, 59037
Service de Cardiologie - CHU de Limoges
Limoges, 87042
Service de Cardiologie - CHU Timone Adultes
Marseille, 13385
Département de Cardiologie - CHU de Montpellier
Montpellier, 34295
Service de Cardiologie - Institut du Thorax - Hôpital Laennec
Nantes, 44093
Service de Cardiologie - Hôpital Pasteur
Nice, 06002
Service de Cardiologie - CHU de Nîmes
Nîmes, 30029
Service de Cardiologie - Hôpital Européen Georges Pompidou
Paris, 75015
Service de Cardiologie - Hôpital Lariboisière
Paris, 75475
Institut de Cardiologie - Hôpital de la Pitité Salpétrière
Paris, 75651
Hôpital Cardiologique du Haut Lévêque - CHU de Bordeaux
Pessac, 33604
Service médico-chirurgical de Cardiologie - CHU de Poitiers
Poitiers, 86021
Département de Cardiologie - CHU de Reims
Reims, 51092
Département de Cardiologie et Maladies Vasculaires - Hôpital de Pontchaillou
Rennes, 35033
Service de Cardiologie - Hôpital Charles Nicolle
Rouen, 76031
Service de Cardiologie - CHU de Saint Etienne
Saint-Etienne, 42000
Service de Cardiologie - Hôpital de Hautepierre
Strasbourg, 67098
Service de Chirurgie Cardiovasculaire - Hôpital Rangueil
Toulouse, 31059
Service de Cardiologie B - Hôpital Trousseau
Tours, 37044
Département de Cardiologie - CHU de Nancy-Brabois
Vandœuvre-lès-Nancy, 54511
About this study
The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.
The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up.
Read the detailed description
The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.
The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up. Thanks to an open label, randomized, 2 arms study : one using a telephone follow up, the other a conventional follow-up.
- Conditions
- Defibrillators, Implantable, Telemedicine
- Being tested
- Tele- follow-up, Conventional follow-up
- Keywords
- Tele medicine, ICD follow-up, Cost / benefit study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele- follow-upOther
Remote transmission to the implantation centre every 3 months
Conventional follow-upOther
Visits at the implantation centre every 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tele- follow-up: remote transmission to the implantation centre every 3 months Receives: Other: Tele- follow-up |
| 2 | Active comparator | Conventional follow-up: visits at the implantation centre every 3 months Receives: Other: Conventional follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.
Measured: 1 year
Secondary outcomes (11)
Time to onset of the first major cardiovascular event (censored criterion)
Measured: 1 year
Death rate
Measured: 1 year
Hospitalisation rate for a cardiovascular event
Measured: 1 year
Rate of unsuccessful or inappropriate ICD therapies
Measured: 1 year
Mean costs of each follow-up strategy
Measured: 1 year
Number of non programmed additional consultations at the implantation centre
Measured: 1 year
Number and cause of device re-programming
Measured: 1 year
Number of drop-outs in the tele-follow-up group
Measured: 1 year
Adherence of the patients to the tele-follow-up strategy
Measured: 1 year
Feasibility of the tele-follow-up in implantation centres
Measured: 1 year
Cost-benefit analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study start14 Jan 2008
- Primary completion7 Mar 2011
- Study completion7 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defibrillators, ImplantableStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Philippe MABO, MD, PhD, Study director, Rennes University HospitalEric BELLISSANT, MD, PhD, Study chair, Rennes University HospitalIsabelle DURAND-ZALESKI, MD, PhD, Study chair, Creteil University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598026
- Sponsor's protocol ID
- 35RC07_9901
- Other IDs
- 0203/076, 2007-A00888-45, LOC/07-04
- Acronym
- EVATEL
- Status last verified
- May 2023
- First submitted
- 9 Jan 2008
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
- ClinicalTrials.gov ID
- NCT00598026
- Acronym / sponsor ID
- EVATEL / 35RC07_9901
- Conditions
- Defibrillators, Implantable, Telemedicine
- Keywords
- Tele medicine, ICD follow-up, Cost / benefit study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,501 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 14 Jan 2008 (actual)
- Primary completion
- 7 Mar 2011 (actual)
- Study completion
- 7 Mar 2011 (actual)
- First posted
- 18 Jan 2008 (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 implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.
The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up.
Detailed description
The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.
The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up. Thanks to an open label, randomized, 2 arms study : one using a telephone follow up, the other a conventional follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Tele- follow-upTele- follow-up: remote transmission to the implantation centre every 3 months |
| 2 | Active comparator | Other: Conventional follow-upConventional follow-up: visits at the implantation centre every 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults over 18,
- First implantation of an implantable cardioverter defibrillator device (CRT-D devices being excluded), single or dual-chamber in primary or secondary prevention,
- ICD with data-transmission features,
- GSM mobile phone network at patient home compatible with remote transmission,
- Patient able to use correctly the transmission system,
Key exclusion criteria (3 listed)
- Class IV of NYHA,
- Concomitant pathology leading to a life expectancy inferior to the protocol duration,
- Concomitant participation to another protocol.
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 |
|---|---|---|
| Tele- follow-upRemote transmission to the implantation centre every 3 months | Other | 1 |
| Conventional follow-upVisits at the implantation centre every 3 months | Other | 2 |
Primary outcome
Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.
Time frame: 1 year
11 secondary outcomes
Time to onset of the first major cardiovascular event (censored criterion)
Time frame: 1 year
Death rate
Time frame: 1 year
Hospitalisation rate for a cardiovascular event
Time frame: 1 year
Rate of unsuccessful or inappropriate ICD therapies
Time frame: 1 year
Mean costs of each follow-up strategy
Time frame: 1 year
Number of non programmed additional consultations at the implantation centre
Time frame: 1 year
Number and cause of device re-programming
Time frame: 1 year
Number of drop-outs in the tele-follow-up group
Time frame: 1 year
Adherence of the patients to the tele-follow-up strategy
Time frame: 1 year
Feasibility of the tele-follow-up in implantation centres
Time frame: 1 year
Cost-benefit analysis
Time frame: 1 year
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 11 May 2023.
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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.
Philippe MABO, MD, PhD study director
Rennes University Hospital
Eric BELLISSANT, MD, PhD study chair
Rennes University Hospital
Isabelle DURAND-ZALESKI, MD, PhD study chair
Creteil University Hospital
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele- follow-up and Conventional follow-up in people with Defibrillators, Implantable and Telemedicine, run by Rennes University Hospital at 30 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 6 inclusion and 3 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023.