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

Primary Purpose

Heart Failure, Cardiac Resynchronization Therapy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CRT-P or CRT-D standard remote monitoring
CRT-P or CRT-D full remote monitoring
Symptoms and signs remote monitoring
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Remote monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut coeur poumon, CHRU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard remote monitoring

Comprehensive remote monitoring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 19, 2016
Last Updated
October 14, 2022
Sponsor
University Hospital, Lille
Collaborators
Biotronik France
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1. Study Identification

Unique Protocol Identification Number
NCT03012490
Brief Title
Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy
Acronym
ECOST-CRT
Official Title
Efficacy, Safety and Cost of Comprehensive Versus Standard Remote Monitoring of Patients With Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
June 9, 2020 (Actual)
Study Completion Date
June 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Biotronik France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Resynchronization Therapy
Keywords
Remote monitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
652 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard remote monitoring
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Comprehensive remote monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CRT-P or CRT-D standard remote monitoring
Intervention Description
standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system
Intervention Type
Other
Intervention Name(s)
CRT-P or CRT-D full remote monitoring
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Symptoms and signs remote monitoring
Intervention Description
symptoms and clinical signs of the patient
Primary Outcome Measure Information:
Title
composite criteria including death from any cause and hospitalization for worsening HF
Time Frame
during the 27 months follow-up
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Guedon-Moreau, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut coeur poumon, CHRU
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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