An interventional study of His bundle pacing, AV optimized and Backup VVI pacing in Atrioventricular Block and Atrioventricular Dyssynchrony, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Treatment
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.
112 studies on the registry are indexed under Atrioventricular Block; 41 are open to participants now.
This study's enrollment of 17 is below the median of 120 across 80 interventional studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →University Medical Centre Ljubljana is the lead sponsor of 294 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
Pacemaker programmed to DDD mode with ventricular lead placed on the bundle of His and echocardiographically optimized AV delay.
Device: His bundle pacing, AV optimized
Pacemaker programmed to ventricular only pacing with low base rate (40/min) to allow intrinsic rhythm.
Device: Backup VVI pacing
A Select Secure 3830 (Medtronic, MN, USA) pacing lead will be placed on the bundle of His. In case of unsuccessful His capture, left bundle branch area pacing is going to be targeted. Pacemaker will be programmed to a low base rate and a high tracking rate to allow for intrinsic sinus rhythm. AV delay will be optimized with echocardiography to the shortest AV delay without truncation of the A wave on transmitral pulse wave doppler.
Pacemaker will be programmed to VVI (ventricular only) mode with low base rate as to allow for intrinsic sinus rhythm without AV optimization.
Changes in exercise capacity
Measured by peak oxygen consumption on cardiopulmonary exercise test
Time frame: Baseline, 3 months, 6 months
Changes in left ventricular stroke volume
Measured by echocardiography
Time frame: Baseline, 3 months, 6 months
Changes in quality of life using the 5 level EQ-5D questionnaire
EQ-5D is a standardized measure of health status consisting of 2 pages - the EQ-5D descriptive system (descriptive system with five levels) and the EQ visual analog scale ranging from 0 (worst state) to 100 (best state).
Time frame: Baseline, 3 months, 6 months
Changes in left ventricular volume
End diastolic volume measured echocardiographicaly with biplane Simpson method
Time frame: Baseline, 3 months, 6 months
Changes in left atrial volume
Left atrial volume indexed by body surface area measured by echocardiography
Time frame: Baseline, 3 months, 6 months
Changes in the measure of left ventricular mechanical dyssynchrony
Measured by mid-ventricular radial speckle-tracking strain with an anteroseptal to posterior wall delay (AS-P delay)
Time frame: Baseline, 3 months, 6 months
Changes in QRS complex width
Measured by electrocardiogram
Time frame: Baseline, 3 months, 6 months
Changes in pacing thresholds
Measured during device check
Time frame: Baseline, 3 months, 6 months
Changes in sensing of R wave
Measured during device check
Time frame: Baseline, 3 months, 6 months
Changes in lead impedance
Measured during device check
Time frame: Baseline, 3 months, 6 months
Fluoroscopy time
Time of fluoroscopy use during device implantation
Time frame: Baseline
Adverse events
Any of the following adverse events: pocket hematoma, pneumothorax, hemothorax, cardiac tamponade, lead dislocation, lead perforation, cardiac implantable device infection
Time frame: through study completion, an average of one year
Plan to share: Yes
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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