Background
Methods
Study design
Study population
Inclusion criteria | |
Symptomatic heart failure (NYHA class II–IV despite OMT) | |
ECG with LBBB according to the Strauss criteria [37] or indwelling single or dual chamber pacemaker and a paced QRS ≥ 180 ms | |
LVEF ≤ 35% | |
Age ≥ 40 years | |
Written informed consent | |
Exclusion criteria | |
Expected lifetime < 6 months | |
Expected cardiac surgery within the next 6 months | |
Recent (< 3 months) myocardial infarction or CABG | |
Pregnant or lactating |
Ethical considerations
Baseline functional and clinical evaluation
Echocardiography
Assessment of cardiac venous anatomy and LV lead position by cardiac CT
Localization of the myocardial scar
Randomization and blinding procedures
The applied strategies for cardiac resynchronization therapy
Endpoints
-
All-cause mortality.
-
Hospitalization for heart failure.
-
Implantation procedure time.
-
Procedural radiation exposure.
-
Device-related complications.
-
Indices of dyssynchrony and association between dyssynchrony, LV lead placement, and response to CRT.
-
Changes in QoL, NYHA functional class, 6MWT, N-terminal prohormone of brain natriuretic peptide (Nt Pro-BNP), QRS duration, LV end-diastolic volume (LVEDV), LVESV, LVEF, mechanical dyssynchrony, and LV lead parameters (pacing threshold, sensing value, impedance).