Cardiac Resynchronization Therapy, Heart Failure
Conditions
Keywords
Remote monitoring
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.
Interventions
OTHERCRT-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
OTHERCRT-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
OTHERSymptoms and signs remote monitoring
symptoms and clinical signs of the patient
Sponsors
University Hospital, Lille
Biotronik France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite criteria including death from any cause and hospitalization for worsening HF | during the 27 months follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs | 27 months |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLaurence Guedon-Moreau, MD
University Hospital, Lille
Outcome results
None listed