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

Heart Failure, Systolic Clinical Trial

— HIS-PrEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04529577
• Other study ID #: HIS-PrEF_study
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: Maiwand Farouq, MD, PhD
• Phone: + 46 40 336415?
• Email: maiwand.farouq[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• His Bundle Pacing
• Systolic Murmurs

Intervention

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.

Locations

Country	Name	City	State
Sweden	Skane University Hospital	Lund
Sweden	Norrland University Hospital	Umeå
Sweden	Region Hallands Sjukhus Varberg	Varberg

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection Fraction	Absolute difference in left ventricular systolic ejection fraction (absolute percent)	6 months
Secondary	Adverse events	Percentage of device-related adverse events. Events will be classified as general, associated with His-bundle lead or associated with RV lead	12 months
Secondary	Left ventricular activation time	Total left ventricular mechanical activation time (measured with tissue doppler echocardiography)	6 months
Secondary	NT-ProBNP	Difference in NT-ProBNP levels	6 months
Secondary	QRS duration	Difference in total QRS duration on ECG	6 months
Secondary	Left Ventricular Activation Time (LVAT)	Maximum unipolar spike-to-peak-T-wave in V5-V6	6 months
Secondary	6 minute walk test	Difference in six minute hall walk test (meters)	6 months
Secondary	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)	6 months
Secondary	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)	6 months