Impact of Atrio-ventricular Optimization With His Bundle Pacing on Treatment of Atrio-ventricular Dromotropathy

Not Applicable

Completed

• Conditions: Atrioventricular Dyssynchrony; Atrioventricular Block
• Interventions: Device: His bundle pacing, AV optimized; Device: Backup VVI pacing

• Registration Number: NCT04544345
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-12-23
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-10
• Primary Completion: 2022-09-13
• Study Completion: 2023-01-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• First OR second degree Mobitz type 1 atrioventricular block with a PR interval > 250 ms
• left ventricular ejection fraction > 50%
• echocardiographic criteria of atrioventricular dyssynchrony (diastolic filling time/RR interval ratio < 0,4 OR fusion of E and A waves OR diastolic mitral regurgitation)
• symptoms on exertion (dyspnea, palpitations)
• insufficient shortening of PR interval during exercise (PR interval > 200 ms at heart rate of 100 beats per minute)

Exclusion Criteria

• left ventricular ejection fraction < 50%
• third degree atrioventricular block
• atrial fibrillation
• sinus node disease
• left bundle branch block
• right bundle branch block
• ventricular arrhythmia that indicates implantation of cardioverter defibrillator
• consumption of drugs that influence atrioventricular conduction
• active bacterial infection
• inability to undergo cardiopulmonary exercise test
• anaemia (haemoglobin concentration < 100 g/L)
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
His bundle pacing, AV optimized	His bundle pacing, AV optimized	Pacemaker programmed to DDD mode with ventricular lead placed on the bundle of His and echocardiographically optimized AV delay.
Backup VVI pacing	Backup VVI pacing	Pacemaker programmed to ventricular only pacing with low base rate (40/min) to allow intrinsic rhythm.

Primary Outcome Measures

Name	Time	Method
Changes in left ventricular stroke volume	Baseline, 3 months, 6 months	Measured by echocardiography
Changes in quality of life using the 5 level EQ-5D questionnaire	Baseline, 3 months, 6 months	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).
Changes in exercise capacity	Baseline, 3 months, 6 months	Measured by peak oxygen consumption on cardiopulmonary exercise test

Secondary Outcome Measures

Name	Time	Method
Changes in left atrial volume	Baseline, 3 months, 6 months	Left atrial volume indexed by body surface area measured by echocardiography
Changes in left ventricular volume	Baseline, 3 months, 6 months	End diastolic volume measured echocardiographicaly with biplane Simpson method
Changes in the measure of left ventricular mechanical dyssynchrony	Baseline, 3 months, 6 months	Measured by mid-ventricular radial speckle-tracking strain with an anteroseptal to posterior wall delay (AS-P delay)
Changes in lead impedance	Baseline, 3 months, 6 months	Measured during device check
Fluoroscopy time	Baseline	Time of fluoroscopy use during device implantation
Changes in sensing of R wave	Baseline, 3 months, 6 months	Measured during device check
Adverse events	through study completion, an average of one year	Any of the following adverse events: pocket hematoma, pneumothorax, hemothorax, cardiac tamponade, lead dislocation, lead perforation, cardiac implantable device infection
Changes in QRS complex width	Baseline, 3 months, 6 months	Measured by electrocardiogram
Changes in pacing thresholds	Baseline, 3 months, 6 months	Measured during device check

Trial Locations

Locations (1)

UMC Ljubljana; 🇸🇮 Ljubljana, Slovenia