I50.13
Conditions
Interventions
Group 1: Arm 1 comprises cardiac resynchronization therapy (CRT) with combined stimulation of the left ventricle via left bundle branch area pacing (LBBAP) and coronary sinus stimulation (LV-CS), refe
Sponsors
Evangelisches Waldkrankenhaus Spandau
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: HFrEF, LVEF<35%, LBBB on ECG
Exclusion criteria
Exclusion criteria: Age <18 Known anatomical anomalies of CS or other anatomical obstacles for placing the LBBAP or CS lead.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of QRS width in 12-lead ECG between the three stimulation modes (LBBAP-only, LBBAP+LV-CS, LV-CS only) after four weeks per mode. The hypothesis is that the combined stimulation (LBBAP+LV-CS, Super-CRT) yields the narrowest QRS width | — |
Secondary
| Measure | Time frame |
|---|---|
| comparison of echocardiographic parameters (cardiac index, left ventricular ejection fraction (LVEF), strain) between the three stimulation modes (LBBAP-only, LBBAP+LV-CS, LV-CS only) after four weeks per mode. Comparison of NTproBNP levels between the stimulation modes after four weeks per mode. Comparison of subjective well-being using the VAS (Visual Analog Scale) between the stimulation modes after four weeks per mode. The hypothesis is that the combined stimulation (LBBAP+LV-CS, Super-CRT) yields the best results | — |
Countries
Germany
Contacts
Public ContactDavit Saghabalyan
Evangelisches Waldkrankenhaus Spandau
Outcome results
None listed