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OpenTrials
Completed

NCT Number: NCT03012490

Efficacy, Safety and Cost of 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.

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Key information

Conditions

Heart Failure Cardiac Resynchronization Therapy Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut coeur poumon, CHRU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Symptoms and signs remote monitoring

Other

symptoms and clinical signs of the patient

Primary outcomes

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

    Time frame: 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

    Time frame: 27 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Biotronik France

Registry information

Official study title

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

Acronym: ECOST-CRT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2017
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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