An interventional study of His-bundle pacing in His Bundle Pacing and Heart Failure, Systolic, sponsored by Region Skane. Recruiting at 3 sites in Sweden. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
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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.
230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 165 interventional studies indexed under Heart Failure, Systolic.
Browse Heart Failure, Systolic studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients are allocated to receive His-bundle pacing for a period of 6 months. Then the patients will cross over to traditional right ventricular (RV) apical pacing for 6 months.
Device: His-bundle pacing
Patients are allocated to receive traditional RV apical pacing for a period of 6 months. Then the patients will cross over to His-bundle pacing for 6 months.
Device: His-bundle pacing
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.
Ejection 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)
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
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2020 (actual). Primary completion is estimated for Dec 2025, 60 months after the start.
Of 52 non-industry interventional studies with no phase under Heart Failure, Systolic, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's planned 60 months is above that.
Counting every sponsor, half of 56 studies reached it within 30 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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