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

RECRUITINGN/ASponsored by Region Skane
Actively Recruiting
PhaseN/A
SponsorRegion Skane
Started2020-12-01
Est. completion2025-12-01
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04529577

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.

Eligibility

Age: 18 Years – 100 YearsHealthy volunteers accepted
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)

Conditions3

Heart DiseaseHeart Failure SystolicHis Bundle Pacing

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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