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

NCT03012490 | Completed DMC

• 2 other identifiers: 2016_032016-A00873-48
• Study Type: interventional
• Target: 652
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Cardiac Resynchronization Therapy

Keywords

Remote monitoring

Outcome Measures

Primary Outcomes (1)

• composite criteria including death from any cause and hospitalization for worsening HF

  during the 27 months follow-up

Secondary Outcomes (1)

• Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs

  27 months

Study Arms (2)

Standard remote monitoring

ACTIVE COMPARATOR

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

Comprehensive remote monitoring

EXPERIMENTAL

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

Interventions

CRT-P or CRT-D standard remote monitoring OTHER

standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system

Comprehensive remote monitoring; Standard remote monitoring

CRT-P or CRT-D full remote monitoring OTHER

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

Comprehensive remote monitoring

Symptoms and signs remote monitoring OTHER

symptoms and clinical signs of the patient

Comprehensive remote monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Biotronik France: collaborator

Study Sites (1)

Institut coeur poumon, CHRU

Lille, France

Location

Related Publications (1)

• Klein C, Kouakam C, Lazarus A, de Groote P, Bauters C, Marijon E, Mouquet F, Degand B, Guyomar Y, Mansourati J, Leclercq C, Guedon-Moreau L; ECOST-CRT study Investigators. Comprehensive vs. standard remote monitoring of cardiac resynchronization devices in heart failure patients: results of the ECOST-CRT study. Europace. 2024 Oct 3;26(10):euae233. doi: 10.1093/europace/euae233.

  PMID: 39400005 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Laurence Guedon-Moreau, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 6, 2017
• Study Start: February 27, 2017
• Primary Completion: June 9, 2020
• Study Completion: June 9, 2020
• Last Updated: February 5, 2026

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)