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

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.

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