Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy, Safety and Cost of Comprehensive Versus Standard Remote Monitoring of Patients With Cardiac Resynchronization Therapy

Conditions
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Heart Failure, Cardiac Resynchronization Therapy

Intervention / Treatment
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* Other: CRT-P or CRT-D standard remote monitoring
* Other: CRT-P or CRT-D full remote monitoring
* Other: Symptoms and signs remote monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard remote monitoring<br>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. | Other: CRT-P or CRT-D standard remote monitoring<br>* standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system<br>|
| Experimental: Comprehensive remote monitoring<br>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. | Other: CRT-P or CRT-D standard remote monitoring<br>* standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system<br>Other: CRT-P or CRT-D full remote monitoring<br>* 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<br>Other: Symptoms and signs remote monitoring<br>* symptoms and clinical signs of the patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite criteria including death from any cause and hospitalization for worsening HF |  | during the 27 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote monitoring