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

Region Skane

Status: Enrolling

Conditions: Heart Failure, Systolic; His Bundle Pacing

Treatments: Device: His-bundle pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT04529577

HIS-PrEF_study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

His-bundle pacing first

Experimental group

Description:

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.

Treatment:

Device: His-bundle pacing

RV apical pacing first

Experimental group

Description:

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.

Treatment:

Device: His-bundle pacing