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

Not Applicable

Completed

• Conditions: Cardiac Resynchronization Therapy; Heart Failure
• Interventions: Other: CRT-P or CRT-D standard remote monitoring; Other: CRT-P or CRT-D full remote monitoring; Other: Symptoms and signs remote monitoring

• Registration Number: NCT03012490
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Study Start: 2017-02-27
• Primary Completion: 2020-06-09
• Study Completion: 2020-06-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 652

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard remote monitoring	CRT-P or CRT-D standard 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.
Comprehensive remote monitoring	Symptoms and signs remote monitoring	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.
Comprehensive remote monitoring	CRT-P or CRT-D full remote monitoring	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.
Comprehensive remote monitoring	CRT-P or CRT-D standard remote monitoring	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.

Primary Outcome Measures

Name	Time	Method
composite criteria including death from any cause and hospitalization for worsening HF	during the 27 months follow-up

Secondary Outcome Measures

Name	Time	Method
Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs	27 months

Trial Locations

Locations (1)

Institut coeur poumon, CHRU; 🇫🇷 Lille, France