failure of heart function heart failure
Conditions
Interventions
none
Sponsors
Medtronic Trading NL BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Dual or triple chamber ICD/CRT-D device implanted for more then 1 month (the device is a Secura® DR, Consulta® CRT-D, Concerto® II CRT-D, Virtuoso® II DR, Maximo® II DR or a Maximo® II CRT-D; at least one sensing lead in the right atrium and one lead in the right ventricle. 2) Systolic Heart Failure and is at the moment of enrollment in NYHA class II or III 3) Linker ventriculaire ejection fraction of less than 40% 4) Patient has had a HF-related hospitalization in the past 12 months (see protocol p.9)
Exclusion criteria
Exclusion criteria: The patient: 1) needs permanent atrial pacing (>10%) 2) requires additional RAMware downloads after study enrollment 3) has (intermittent) 2nd or intermittent 3rd degree block 4) has persistent or permanent Atrial Fibrillation 5) has had recent (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Het gecombineerde primaire eindpunt is hartfalen gerelateerde hospitalisatie en hartfalen gerelateerd overlijden. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Find the best combination of HRT-TO, HRT-TS, DC and AC to differentiate between the state of a patient at baseline and at during HF related hospitalization/death. • Determine the optimal threshold settings (fixed or adaptive) for the algorithm, in case it would be used to alarm the patient/physician for HF decompensation. • Determine the correlation between the Optivol parameter (alert in case of fluidretention in lungs) and the HRT/DC/AC parameters. • Determine the correlation between bodyweight and the HRT/DC/AC parameters. • Characterize the incidence of premature heart contractions (PVCs) in Heart Failure patients. • Asses preditive value of HRT/AC/DC in relation to ventricular tachycardias (VT/VF episodes) • Determine the correlation between the HRV, Activity, Night HR, VT and AF parameters, AF parameters (available by default via Cardiac Compass), and the HRT/DC/AC parameters. | — |
Countries
Netherlands
Outcome results
None listed