Heart failure
Conditions
Interventions
A pacemaker or defibrillator associated with a CRT system will be implanted according to the standard care procedures. The decision to implant a pacemaker or a defibrillator associated with CRT system
Sponsors
Clermont-Ferrand University Hospital
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients over 18 years* old - NYHA class II to IV ambulatory - QRS duration > 130 ms - Patients with sinus rhythm - LVEF
Exclusion criteria
Exclusion criteria: - Inability to understand nor decline the study, - Impaired mobility, - Unable to fill out questionnaire independently, - Patients with permanent atrial fibrillation, - Pregnant women, - Dependant adult, - Patients minor, - Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of 2 clinical endpoints (12 months all-cause deaths and percentage of hospitalizations for HF at 12 months) combined using an average z-score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of efficacy, analysis of: - 12- month deaths (HF, cardiovascular and all causes deaths), - Quality-of-life questionnaires at 6 and 12 months: o Minnesota Living With Heart Failure Questionnaire: MLWHFQ): improvement of at least 20 points - Functional capacity at 6 and 12 months: o NYHA classification reduction >= 1 class, o 6-minute walk test improvement of at least 10 % in distance, o Peak oxygen consumption increased by 1.0 ml/kg/min13, - Percentage of hospitalizations for HF, for cardiovascular reasons and for allcauses at 6 and 12 months, - Decrease >15% in end-diastolic and/or end-systolic volumes of the left ventricle at 6 and 12 months. Packer score assessment | — |
Countries
France, Netherlands
Contacts
Public ContactR Eschalie
Clermont-Ferrand University Hospital
Outcome results
None listed