Skip to main content
OpenTrials
Completed

NCT Number: NCT04544345

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrioventricular Block Arrhythmias, Cardiac Atrioventricular Dyssynchrony Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

His bundle pacing, AV optimized

Device

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.

Backup VVI pacing

Device

Pacemaker will be programmed to VVI (ventricular only) mode with low base rate as to allow for intrinsic sinus rhythm without AV optimization.

Primary outcomes

  1. Changes in exercise capacity

    Time frame: Baseline, 3 months, 6 months

    Measured by peak oxygen consumption on cardiopulmonary exercise test

  2. Changes in left ventricular stroke volume

    Time frame: Baseline, 3 months, 6 months

    Measured by echocardiography

  3. Changes in quality of life using the 5 level EQ-5D questionnaire

    Time frame: 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).

Secondary outcomes

  1. Changes in left ventricular volume

    Time frame: Baseline, 3 months, 6 months

    End diastolic volume measured echocardiographicaly with biplane Simpson method

  2. Changes in left atrial volume

    Time frame: Baseline, 3 months, 6 months

    Left atrial volume indexed by body surface area measured by echocardiography

  3. Changes in the measure of left ventricular mechanical dyssynchrony

    Time frame: Baseline, 3 months, 6 months

    Measured by mid-ventricular radial speckle-tracking strain with an anteroseptal to posterior wall delay (AS-P delay)

  4. Changes in QRS complex width

    Time frame: Baseline, 3 months, 6 months

    Measured by electrocardiogram

  5. Changes in pacing thresholds

    Time frame: Baseline, 3 months, 6 months

    Measured during device check

  6. Changes in sensing of R wave

    Time frame: Baseline, 3 months, 6 months

    Measured during device check

  7. Changes in lead impedance

    Time frame: Baseline, 3 months, 6 months

    Measured during device check

  8. Fluoroscopy time

    Time frame: Baseline

    Time of fluoroscopy use during device implantation

  9. Adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Sep 10, 2020
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.