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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Cardiac Resynchronization Therapy
• Intervention / 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

• Study Type: Interventional
• Enrollment (Actual): 652
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Institut Coeur Poumon, CHRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Biotronik France
• Investigators: Principal Investigator: Laurence Guedon-Moreau, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): June 9, 2020
• Study Completion (Actual): June 9, 2020

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Remote monitoring
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2016_03; 2016-A00873-48 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No