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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04529577
Study type Interventional
Source Region Skane
Contact Maiwand Farouq, MD, PhD
Phone + 46 40 336415?
Email maiwand.farouq@skane.se
Status Recruiting
Phase N/A
Start date December 1, 2020
Completion date December 2025

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