His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection Fraction

Not Applicable

Recruiting

• Conditions: Heart Failure, Systolic; His Bundle Pacing
• Interventions: Device: His-bundle pacing

• Registration Number: NCT04529577
• Lead Sponsor: Region Skane

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-27
• Study Start: 2020-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RV apical pacing first	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.
His-bundle pacing first	His-bundle pacing	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.

Primary Outcome Measures

Name	Time	Method
Ejection Fraction	6 months	Absolute difference in left ventricular systolic ejection fraction (absolute percent)

Secondary Outcome Measures

Name	Time	Method
Left Ventricular Activation Time (LVAT)	6 months	Maximum unipolar spike-to-peak-T-wave in V5-V6
QRS duration	6 months	Difference in total QRS duration on ECG
6 minute walk test	6 months	Difference in six minute hall walk test (meters)
Adverse events	12 months	Percentage of device-related adverse events. Events will be classified as general, associated with His-bundle lead or associated with RV lead
Change in quality of life measured by the Short Form Health Survey (SF-36) mean score	6 months	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)
Left ventricular activation time	6 months	Total left ventricular mechanical activation time (measured with tissue doppler echocardiography)
Change in quality of life measured by the EuroQol EQ-5D-5L Questionnaire	6 months	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)
NT-ProBNP	6 months	Difference in NT-ProBNP levels

Trial Locations

Locations (3)

Region Hallands Sjukhus Varberg; 🇸🇪 Varberg, Sweden

Norrland University Hospital; 🇸🇪 Umeå, Sweden

Skane University Hospital; 🇸🇪 Lund, Sweden