Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy (ECOST-CRT)
Heart Failure, Cardiac Resynchronization Therapy
About this trial
This is an interventional prevention trial for Heart Failure focused on measuring Remote monitoring
Eligibility Criteria
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
Sites / Locations
- Institut coeur poumon, CHRU
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard remote monitoring
Comprehensive remote monitoring
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.
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.