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

Sponsor

Region Skane (Other)

Overall Status

Recruiting

CT.gov ID

NCT04529577

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

13.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
His Bundle Pacing Heart Failure, Systolic	Device: His-bundle pacing	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized double blinded crossover design.Randomized double blinded crossover design.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Patients and outcomes assessors are blinded. Staff involved in device programming are not blinded.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: His-bundle pacing first 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 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.
Experimental: RV apical pacing first 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.

Arm

Intervention/Treatment

Experimental: His-bundle pacing first

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

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.

Experimental: RV apical pacing first

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

Outcome Measures

Primary Outcome Measures

Ejection Fraction [6 months]
Absolute difference in left ventricular systolic ejection fraction (absolute percent)

Secondary Outcome Measures

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
Left ventricular activation time [6 months]
Total left ventricular mechanical activation time (measured with tissue doppler echocardiography)
NT-ProBNP [6 months]
Difference in NT-ProBNP levels
QRS duration [6 months]
Difference in total QRS duration on ECG
Left Ventricular Activation Time (LVAT) [6 months]
Maximum unipolar spike-to-peak-T-wave in V5-V6
6 minute walk test [6 months]
Difference in six minute hall walk test (meters)
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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)