Status:
RECRUITING
His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection Fraction
Lead Sponsor:
Region Skane
Conditions:
His Bundle Pacing
Heart Failure, Systolic
Eligibility:
All Genders
18-100 years
Phase:
NA
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 pace...
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 des...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04529577
Start Date
December 1 2020
End Date
December 1 2025
Last Update
February 28 2025
Active Locations (3)
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1
Skane University Hospital
Lund, Sweden
2
Norrland University Hospital
Umeå, Sweden
3
Region Hallands Sjukhus Varberg
Varberg, Sweden