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Atrioventricular BlockNCT04544345

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

A study testing His bundle pacing, AV optimized and Backup VVI pacing in people with Atrioventricular Block and Atrioventricular Dyssynchrony, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
His bundle pacing, AV optimized and Backup VVI pacing
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteSlovenia
Study dates
23 Dec 2019to 4 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • left ventricular ejection fraction < 50%
  • third degree atrioventricular block
  • atrial fibrillation
  • sinus node disease
  • left bundle branch block
  • right bundle branch block
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • UMC Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

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.

Read the 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.

Being tested
His bundle pacing, AV optimized, Backup VVI pacing
Keywords
AV block, His bundle pacing, AV dyssynchrony, AV optimization, AV dromotropathy, First degree AV block, Peak oxygen uptake
Medical subject headings
Atrioventricular Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • His bundle pacing, AV optimizedDevice

    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 pacingDevice

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

Study groups in NCT04544345
Study groupRoleWhat they receive
His bundle pacing, AV optimizedExperimentalPacemaker programmed to DDD mode with ventricular lead placed on the bundle of His and echocardiographically optimized AV delay.
Receives: Device: His bundle pacing, AV optimized
Backup VVI pacingSham comparatorPacemaker programmed to ventricular only pacing with low base rate (40/min) to allow intrinsic rhythm.
Receives: Device: Backup VVI pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in exercise capacity

    Measured by peak oxygen consumption on cardiopulmonary exercise test

    Measured: Baseline, 3 months, 6 months

  2. Changes in left ventricular stroke volume

    Measured by echocardiography

    Measured: Baseline, 3 months, 6 months

  3. 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).

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (9)

  1. Changes in left ventricular volume

    End diastolic volume measured echocardiographicaly with biplane Simpson method

    Measured: Baseline, 3 months, 6 months

  2. Changes in left atrial volume

    Left atrial volume indexed by body surface area measured by echocardiography

    Measured: Baseline, 3 months, 6 months

  3. 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)

    Measured: Baseline, 3 months, 6 months

  4. Changes in QRS complex width

    Measured by electrocardiogram

    Measured: Baseline, 3 months, 6 months

  5. Changes in pacing thresholds

    Measured during device check

    Measured: Baseline, 3 months, 6 months

  6. Changes in sensing of R wave

    Measured during device check

    Measured: Baseline, 3 months, 6 months

  7. Changes in lead impedance

    Measured during device check

    Measured: Baseline, 3 months, 6 months

  8. Fluoroscopy time

    Time of fluoroscopy use during device implantation

    Measured: Baseline

  9. Adverse events

    Any of the following adverse events: pocket hematoma, pneumothorax, hemothorax, cardiac tamponade, lead dislocation, lead perforation, cardiac implantable device infection

    Measured: through study completion, an average of one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2020
  2. Study start23 Dec 2019
  3. Primary completion13 Sep 2022
  4. Study completion4 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04544345
Sponsor's protocol ID
UMCLj-AVdromHis
Status last verified
Feb 2023
First submitted
26 Aug 2020
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • Salden FCWM, Kutyifa V, Stockburger M, Prinzen FW, Vernooy K. Atrioventricular dromotropathy: evidence for a distinctive entity in heart failure with prolonged PR interval? Europace. 2018 Jul 1;20(7):1067-1077. doi: 10.1093/europace/eux207.

    PubMed 29186415

  • Aro AL, Anttonen O, Kerola T, Junttila MJ, Tikkanen JT, Rissanen HA, Reunanen A, Huikuri HV. Prognostic significance of prolonged PR interval in the general population. Eur Heart J. 2014 Jan;35(2):123-9. doi: 10.1093/eurheartj/eht176. Epub 2013 May 14.

    PubMed 23677846

  • Iliev II, Yamachika S, Muta K, Hayano M, Ishimatsu T, Nakao K, Komiya N, Hirata T, Ueyama C, Yano K. Preserving normal ventricular activation versus atrioventricular delay optimization during pacing: the role of intrinsic atrioventricular conduction and pacing rate. Pacing Clin Electrophysiol. 2000 Jan;23(1):74-83. doi: 10.1111/j.1540-8159.2000.tb00652.x.

    PubMed 10666756

  • European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA); Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Europace. 2013 Aug;15(8):1070-118. doi: 10.1093/europace/eut206. Epub 2013 Jun 24. No abstract available.

    PubMed 23801827

  • Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23. doi: 10.1001/jama.288.24.3115.

    PubMed 12495391

  • Kiehl EL, Makki T, Kumar R, Gumber D, Kwon DH, Rickard JW, Kanj M, Wazni OM, Saliba WI, Varma N, Wilkoff BL, Cantillon DJ. Incidence and predictors of right ventricular pacing-induced cardiomyopathy in patients with complete atrioventricular block and preserved left ventricular systolic function. Heart Rhythm. 2016 Dec;13(12):2272-2278. doi: 10.1016/j.hrthm.2016.09.027.

    PubMed 27855853

  • Sharma PS, Dandamudi G, Naperkowski A, Oren JW, Storm RH, Ellenbogen KA, Vijayaraman P. Permanent His-bundle pacing is feasible, safe, and superior to right ventricular pacing in routine clinical practice. Heart Rhythm. 2015 Feb;12(2):305-12. doi: 10.1016/j.hrthm.2014.10.021. Epub 2014 Oct 22.

    PubMed 25446158

  • Abdelrahman M, Subzposh FA, Beer D, Durr B, Naperkowski A, Sun H, Oren JW, Dandamudi G, Vijayaraman P. Clinical Outcomes of His Bundle Pacing Compared to Right Ventricular Pacing. J Am Coll Cardiol. 2018 May 22;71(20):2319-2330. doi: 10.1016/j.jacc.2018.02.048. Epub 2018 Mar 10.

    PubMed 29535066

  • Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.

    PubMed 19723701

  • Kutyifa V, Stockburger M, Daubert JP, Holmqvist F, Olshansky B, Schuger C, Klein H, Goldenberg I, Brenyo A, McNitt S, Merkely B, Zareba W, Moss AJ. PR interval identifies clinical response in patients with non-left bundle branch block: a Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy substudy. Circ Arrhythm Electrophysiol. 2014 Aug;7(4):645-51. doi: 10.1161/CIRCEP.113.001299. Epub 2014 Jun 24.

    PubMed 24963007

  • Joshi NP, Stopper MM, Li J, Beshai JF, Pavri BB. Impact of baseline PR interval on cardiac resynchronization therapy outcomes in patients with narrow QRS complexes: an analysis of the ReThinQ Trial. J Interv Card Electrophysiol. 2015 Aug;43(2):145-9. doi: 10.1007/s10840-015-9999-y. Epub 2015 Apr 29.

    PubMed 25921348

  • Zhang J, Guo J, Hou X, Wang Y, Qian Z, Li K, Ge P, Zou J. Comparison of the effects of selective and non-selective His bundle pacing on cardiac electrical and mechanical synchrony. Europace. 2018 Jun 1;20(6):1010-1017. doi: 10.1093/europace/eux120.

    PubMed 28575215

Questions about this trial

What is this clinical trial studying?

A study testing His bundle pacing, AV optimized and Backup VVI pacing in people with Atrioventricular Block and Atrioventricular Dyssynchrony, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in exercise capacity (time frame: Baseline, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04544345, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023; AzTrials last refreshed its copy on 31 Oct 2026.

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