Heart FailureECOST-CRTNCT03012490
Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy
A study testing CRT-P or CRT-D standard remote monitoring, CRT-P or CRT-D full remote monitoring and Symptoms and signs remote monitoring in people with Heart Failure and Cardiac Resynchronization Therapy, run by University Hospital, Lille at 1 site in France.
Trial summary
The primary objective is to determine whether comprehensive remote follow-up in HF patients with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure hospitalizations, whichever comes first, when compared to basic remote monitoring, over a 27-month follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Resynchronization Therapy
- What is being tested?
- CRT-P or CRT-D standard remote monitoring, CRT-P or CRT-D full remote monitoring and Symptoms and signs remote monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2017to 9 Jun 2020
- 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
- Patient more than 18 years old, newly implanted, in accordance to the latest European guidelines, with a CRT-P or CRT-D device (upgrading is tolerated but no device replacement), with Home-Monitoring® activated
- Patient willing and able to comply with the protocol and who has provided written informed consent
Who cannot join
- Lead model under advisory
- Non-functional lead except particular case of non-functional or deactivated right atrial lead due to atrial fibrillation
- Known drug or alcohol abuse
- Pregnant woman or woman who plan to become pregnant during the trial (the data will be collected by querying the patient without a pregnancy test is required)
- Participation (ongoing or planned during the trial) in another interventional clinical study, and/or another remote monitoring and/or follow-up concept, unless authorized by the Executive Committee
- Participation (ongoing or planned during the trial) in an investigational HF program (e.g. PRADO, PIMPS, OSICAT, CARDIAUVERGNE)
Show all 9Show fewer
- Estimated life-expectancy, regardless of the cardiovascular condition, <1year
- Patient under- or planned for - ventricular assistance
- Patient not living in Metropolitan France and/or not geographically stable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Safety and Cost of Comprehensive Versus Standard Remote Monitoring of Patients With Cardiac Resynchronization Therapy
The primary objective is to determine whether comprehensive remote follow-up in HF patients with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure hospitalizations, whichever comes first, when compared to basic remote monitoring, over a 27-month follow-up.
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Being tested
- CRT-P or CRT-D standard remote monitoring, CRT-P or CRT-D full remote monitoring, Symptoms and signs remote monitoring
- Keywords
- Remote monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-P or CRT-D standard remote monitoringOther
standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system
CRT-P or CRT-D full remote monitoringOther
Full follow-up for the Active group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system + supraventricular rhythm disorders, parameters related to heart failure, including symptoms and clinical signs of the patient
Symptoms and signs remote monitoringOther
symptoms and clinical signs of the patient
| Study group | Role | What they receive |
|---|---|---|
| Standard remote monitoring | Active comparator | Remote monitoring of CRT-P and CRT-D is activated. The physician will only receive the notifications related to technical events and ventricular arrhythmias. Therapy will be added or changed in response to these notifications and/or the symptoms and signs observed during ambulatory visits. Receives: Other: CRT-P or CRT-D standard remote monitoring |
| Comprehensive remote monitoring | Experimental | Remote monitoring of CRT-P and CRT-D is activated, as well as remote assessment of symptoms and signs. In addition to notifications related to technical events and ventricular arrhythmias, the physician will receive notifications related to heart failure parameters, atrial arrhythmias, and patient's symptoms and signs. Therapy will be added or changed in response to these notifications, and/or to the symptoms and signs observed during ambulatory visits. Receives: Other: CRT-P or CRT-D standard remote monitoring; Other: CRT-P or CRT-D full remote monitoring; Other: Symptoms and signs remote monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite criteria including death from any cause and hospitalization for worsening HF
Measured: during the 27 months follow-up
Secondary outcomes (1)
Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs
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 posted6 Jan 2017 (estimated)
- Study start27 Feb 2017
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik France
- Responsible party
- Sponsor
- Investigators
- Laurence Guedon-Moreau, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012490
- Sponsor's protocol ID
- 2016_03
- Other IDs
- 2016-A00873-48
- Acronym
- ECOST-CRT
- Status last verified
- Oct 2022
- First submitted
- 19 Dec 2016
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klein C, Kouakam C, Lazarus A, de Groote P, Bauters C, Marijon E, Mouquet F, Degand B, Guyomar Y, Mansourati J, Leclercq C, Guedon-Moreau L; ECOST-CRT study Investigators. Comprehensive vs. standard remote monitoring of cardiac resynchronization devices in heart failure patients: results of the ECOST-CRT study. Europace. 2024 Oct 3;26(10):euae233. doi: 10.1093/europace/euae233.
PubMed 39400005
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Cost of Comprehensive Versus Standard Remote Monitoring of Patients With Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT03012490
- Acronym / sponsor ID
- ECOST-CRT / 2016_03
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Keywords
- Remote monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Biotronik France
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 6 Jan 2017 (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 primary objective is to determine whether comprehensive remote follow-up in HF patients with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure hospitalizations, whichever comes first, when compared to basic remote monitoring, over a 27-month follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard remote monitoring | Active comparator | Other: CRT-P or CRT-D standard remote monitoringRemote monitoring of CRT-P and CRT-D is activated. The physician will only receive the notifications related to technical events and ventricular arrhythmias. Therapy will be added or changed in response to these notifications and/or the symptoms and signs observed during ambulatory visits. |
| Comprehensive remote monitoring | Experimental | Other: CRT-P or CRT-D standard remote monitoring, Other: CRT-P or CRT-D full remote monitoring, Other: Symptoms and signs remote monitoringRemote monitoring of CRT-P and CRT-D is activated, as well as remote assessment of symptoms and signs. In addition to notifications related to technical events and ventricular arrhythmias, the physician will receive notifications related to heart failure parameters, atrial arrhythmias, and patient's symptoms and signs. Therapy will be added or changed in response to these notifications, and/or to the symptoms and signs observed during ambulatory visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient more than 18 years old, newly implanted, in accordance to the latest European guidelines, with a CRT-P or CRT-D device (upgrading is tolerated but no device replacement), with Home-Monitoring® activated
- Patient willing and able to comply with the protocol and who has provided written informed consent
Key exclusion criteria (9 listed)
- Lead model under advisory
- Non-functional lead except particular case of non-functional or deactivated right atrial lead due to atrial fibrillation
- Known drug or alcohol abuse
- Pregnant woman or woman who plan to become pregnant during the trial (the data will be collected by querying the patient without a pregnancy test is required)
- Participation (ongoing or planned during the trial) in another interventional clinical study, and/or another remote monitoring and/or follow-up concept, unless authorized by the Executive Committee
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 |
|---|---|---|
| CRT-P or CRT-D standard remote monitoringstandard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system | Other | Comprehensive remote monitoring, Standard remote monitoring |
| CRT-P or CRT-D full remote monitoringFull follow-up for the Active group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system + supraventricular rhythm disorders, parameters related to heart failure, including symptoms and clinical signs of the patient | Other | Comprehensive remote monitoring |
| Symptoms and signs remote monitoringsymptoms and clinical signs of the patient | Other | Comprehensive remote monitoring |
Primary outcome
composite criteria including death from any cause and hospitalization for worsening HF
Time frame: during the 27 months follow-up
1 secondary outcome
Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs
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 5 Feb 2026.
- Results publication: PubMed 39400005Klein C, Kouakam C, Lazarus A, de Groote P, Bauters C, Marijon E, Mouquet F, Degand B, Guyomar Y, Mansourati J, Leclercq C, Guedon-Moreau L; ECOST-CRT study Investigators. Comprehensive vs. standard remote monitoring of cardiac resynchronization devices in heart failure patients: results of the ECOST-CRT study. Europace. 2024 Oct 3;26(10):euae233. doi: 10.1093/europace/euae233.
- 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.
Laurence Guedon-Moreau, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT-P or CRT-D standard remote monitoring, CRT-P or CRT-D full remote monitoring and Symptoms and signs remote monitoring in people with Heart Failure and Cardiac Resynchronization Therapy, run by University Hospital, Lille 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 2 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 5 Feb 2026. 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?
composite criteria including death from any cause and hospitalization for worsening HF (time frame: during the 27 months follow-up). 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 NCT03012490, 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 5 Feb 2026.