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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00873-48 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Biotronik France | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-P or CRT-D standard remote monitoring | Other | standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system |
| Measure | Description | Time Frame |
|---|---|---|
| composite criteria including death from any cause and hospitalization for worsening HF | during the 27 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs | 27 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Guedon-Moreau, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut coeur poumon, CHRU | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39400005 | Result | 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. |
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| CRT-P or CRT-D full remote monitoring | Other | 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 |
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| Symptoms and signs remote monitoring | Other | symptoms and clinical signs of the patient |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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