I50.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Age> 18 years - Limited LV-EF (25-45%) - guideline-based drug treatment of chronic heart failure - clinical indication for the use of cardiac contractility modulation (CCM) - written declaration of consent
Exclusion criteria
Exclusion criteria: - lack of consent to participate in the study - Interventional or surgical heart procedure planned within the next 3 months (e.g. PCI, bypass surgery, treatment of a heart valve defect or a structural heart defect) - Inability to evaluate cardiac function by echocardiography - no possibility for a follow-up examination (3-month check-up)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CCM implant in situ? (1: yes; 2: no) mean daily CCM therapy duration (h) NYHA stage (1 to 4) Heart attack (1: yes; 2: no) Stroke (1: yes; 2: no) Hospitalization due to Heart failure (1: yes; 2: no) unplanned hospitalization of any cause (1: yes; 2: no) PCI / catheter intervention / heart surgery other than CCM implantation that has taken place since randomization ((1: yes; 2: no) Death (1: yes; 2: no) | — |
Secondary
| Measure | Time frame |
|---|---|
| cancellation | — |
Countries
Germany
Contacts
Katholisches Krankenhaus Erfurt