heart failure
Conditions
Interventions
For this protocol the sponsor will use a registred/certified device (implant)
for all patients and compare 2 groups. Patients will be randomized to either
1. usual care with RPM *Remote patient mon
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -First time ICD or CRT-D implanted at one of the participating centers -LVEF * 35% (assessed max. 12 months prior to implantation) -NYHA functional class II or III symptoms at time of implantation -ICD/CRT-D device compatible with the LATITUDE® Patient Management system from Boston Scientific (e.g., COGNIS®)
Exclusion criteria
Exclusion criteria: -Younger than 18 or older than 85 years of age -On the waiting list for heart transplantation -History of psychiatric illness other than affective/anxiety disorders -Inability to fill out the questionnaires due to cognitive impairments (e.g. dementia) -Insufficient knowledge of the language to fill in the questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: disease-specific health status, device acceptance | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: 1) satisfaction with RPM 2) cost-effectiveness. | — |
Countries
Netherlands
Outcome results
None listed