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

Heart Failure Clinical Trial

— ECOST-CRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012490
• Other study ID #: 2016_03
• Secondary ID: 2016-A00873-48
• Status: Completed
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: June 9, 2020

Study information

• Verified date: October 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 652
• Est. completion date: June 9, 2020
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure

Intervention

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
• 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
• Symptoms and signs remote monitoring
symptoms and clinical signs of the patient

Locations

Country	Name	City	State
France	Institut coeur poumon, CHRU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Biotronik France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite criteria including death from any cause and hospitalization for worsening HF		during the 27 months follow-up
Secondary	Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs		27 months