Heart Failure, Systolic, His Bundle Pacing
Conditions
Keywords
His bundle pacing, Conduction system pacing, Heart failure, systolic, Quality of life, Left ventricular ejection fraction
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.
Interventions
DEVICEHis-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.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Patients and outcomes assessors are blinded. Staff involved in device programming are not blinded.
Intervention model description
Randomized double blinded crossover design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ejection Fraction | 6 months | Absolute difference in left ventricular systolic ejection fraction (absolute percent) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| Left Ventricular Activation Time (LVAT) | 6 months | Maximum unipolar spike-to-peak-T-wave in V5-V6 |
Countries
Sweden
Contacts
Primary ContactMaiwand Farouq, MD, PhD
Backup ContactRasmus Borgquist, MD
Outcome results
None listed