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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
A standard pacing electrode (Medtronic 4076) will be placed in RV apex (or RV septum as a secondary option) and in the right atrial appendage (if indicated). A dedicated His-bundle pacemaker electrode (Medtronic 3830) will be placed in the region of His bundle, using a dedicated introducer sheath (Medtronic C304 or Medtronic C315). His-bundle potentials will be identified and His-bundle capture (non-selective or selective) will be ascertained using an electrophysiology recording system. Device programming will focus on providing physiological atrioventricular delay and safety RV pacing as backup.
Skane University Hospital
Lund, Sweden
RECRUITINGNorrland University Hospital
Umeå, Sweden
RECRUITINGRegion Hallands Sjukhus Varberg
Varberg, Sweden
RECRUITINGEjection Fraction
Absolute difference in left ventricular systolic ejection fraction (absolute percent)
Time frame: 6 months
Adverse events
Percentage of device-related adverse events. Events will be classified as general, associated with His-bundle lead or associated with RV lead
Time frame: 12 months
Left ventricular activation time
Total left ventricular mechanical activation time (measured with tissue doppler echocardiography)
Time frame: 6 months
NT-ProBNP
Difference in NT-ProBNP levels
Time frame: 6 months
QRS duration
Difference in total QRS duration on ECG
Time frame: 6 months
Left Ventricular Activation Time (LVAT)
Maximum unipolar spike-to-peak-T-wave in V5-V6
Time frame: 6 months
6 minute walk test
Difference in six minute hall walk test (meters)
Time frame: 6 months
Change in quality of life measured by the Short Form Health Survey (SF-36) mean score
Difference in health related quality of life, measured by the SF-36 questionnaire, calculated as difference in mean from baseline to follow-up (calculated using the official scoring algorithm, where each sub scale is assigned a score between 0-100, higher score represents better health)
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Time frame: 6 months
Change in quality of life measured by the EuroQol EQ-5D-5L Questionnaire
Difference in health related quality of life, measured by the mean score of the EQ-5D (version 5L) questionnaire (totalt score ranging from 5-25 points, higher score represents more health related problems/disability)
Time frame: 6 months