His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection Fraction
His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection Fraction
The study compares standard right ventricle apical pacing with so called His-bundle pacing,
 for patients with slightly or moderately reduced ejection fraction and atrioventricular block
 requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction
 measured after 6 months.
Patients with reduced systolic ejection fraction (40≤ ejection fraction ≤55%) and pacemaker
 indication due to high degree AV block are included. The study has a randomized double
 blinded crossover design. Patients are implanted with a standard right ventricle lead and
 right atrial lead (if indicated), and in addition a His-bundle lead. Randomization is
 performed as to which pacing modality is used during the first 6 months. After 6 months the
 pacing modality is changed. Patients are blinded and endpoint adjudicators, including
 echocardiography staff, are blinded. Device nurse and physician are not blinded.

 Primary endpoint is difference in left ventricular ejection fraction after 6 months, paired
 comparisons are used and each patient is their own control. Secondary endpoints include
 complications and safety of the device/electrode, and quality of life.
Inclusion Criteria:

 -  AV block II or III with high expected pacing need

 -  Left ventricular ejection fraction between 40% and 55% (inclusive)

 -  Willing to participate and sign informed consent

 Exclusion Criteria:

 -  Under 18 years old

 -  Pregnant

 -  Hypertrophic cardiomyopathy

 -  Cardiac sarcoidosis

 -  Cardiac amyloidosis

 -  Previous myocardial infarction within last 3 months

 -  Ventricular septum defect or other other left ventricular corrective surgery

 -  Congenital heart disease surgically corrected

 -  Atrial fibrillation with uncontrolled rate (if not planned for AV node ablation)