Clinical trial NCT04529577: His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection Fraction
Official title: His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: His Bundle Pacing
Heart Failure, Systolic
Keywords: His bundle pacing
Conduction system pacing
Heart failure, systolic
Quality of life
Left ventricular ejection fraction
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized double blinded crossover design.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Ejection Fraction
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events
timeFrame: 12 months
measure: Left ventricular activation time
timeFrame: 6 months
measure: NT-ProBNP
timeFrame: 6 months
measure: QRS duration
timeFrame: 6 months
measure: Left Ventricular Activation Time (LVAT)
timeFrame: 6 months
measure: 6 minute walk test
timeFrame: 6 months
measure: Change in quality of life measured by the Short Form Health Survey (SF-36) mean score
timeFrame: 6 months
measure: Change in quality of life measured by the EuroQol EQ-5D-5L Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital
city: Umeå
country: Sweden
facility: Norrland University Hospital
city: Varberg
country: Sweden
facility: Region Hallands Sjukhus Varberg
Study officials:
affiliation: Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden
name: Rasmus Borgquist, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: