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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2020-06-09

Brief Summary

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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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Detailed Description

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Conditions

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Heart Failure Cardiac Resynchronization Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

CRT-P or CRT-D standard remote monitoring

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

CRT-P or CRT-D standard remote monitoring

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

symptoms and clinical signs of the patient

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Symptoms and signs remote monitoring

symptoms and clinical signs of the patient

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No