Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy (ECOST-CRT)

University Hospital, Lille

Status: Completed

Conditions: Cardiac Resynchronization Therapy; Heart Failure

Treatments: Other: Symptoms and signs remote monitoring; Other: CRT-P or CRT-D full remote monitoring; Other: CRT-P or CRT-D standard remote monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03012490

2016_03

2016-A00873-48 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 652 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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652 participants in 2 patient groups

Standard remote monitoring

Active Comparator group

Description:

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.

Treatment:

Other: CRT-P or CRT-D standard remote monitoring

Comprehensive remote monitoring

Experimental group

Description:

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.

Treatment:

Other: CRT-P or CRT-D standard remote monitoring

Other: CRT-P or CRT-D full remote monitoring

Other: Symptoms and signs remote monitoring