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This study aims to determine the clinical and hemodynamic benefit of atrio-ventricular (AV) resynchronization with His bundle pacing in patients with symptomatic first degree AV block.
The term AV dyssynchrony was introduced by Salden F. and coauthors in 2018. It stands for the adverse effects of AV dyssynchrony due to PR interval prolongation. According to the ESC and ACC guidelines, severe first degree AV block is an IIa indication for permanent pacemaker implantation, yet data on these patients' clinical outcomes are scarce. To independently determine the impact of AV resynchronization, His bundle pacing will be used to avoid intraventricular desynchronization. Symptomatic patients with severe first-degree AV block and echocardiographically proven AV dyssynchrony will be included in the study. All patients will receive a dual-chamber pacemaker with an atrial lead positioned in the right atrium and ventricular lead placed on the bundle of His. In a single-blind cross-over design, patients will be randomized to AV sequential His bundle pacing with echo-guided AV optimization or back-up VVI pacing mode. Each study period will last for three months. At the end of both periods, cardiopulmonary exercise testing, complete echocardiographic study, and clinical evaluation will be performed. Peak oxygen uptake and echocardiography-based hemodynamic parameters in both periods will be compared.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
UMC Ljubljana
Ljubljana, Slovenia
Start Date
December 23, 2019
Primary Completion Date
September 13, 2022
Completion Date
January 4, 2023
Last Updated
February 16, 2023
17
ACTUAL participants
His bundle pacing, AV optimized
DEVICE
Backup VVI pacing
DEVICE
Lead Sponsor
University Medical Centre Ljubljana
NCT07236489
NCT07196397
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