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

NCT04544345 | Completed FDA Device

• 1 other identifier: UMCLj-AVdromHis
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrioventricular Block; Atrioventricular Dyssynchrony

Keywords

AV block; His bundle pacing; AV dyssynchrony; AV optimization; AV dromotropathy; First degree AV block; Peak oxygen uptake

Outcome Measures

Primary Outcomes (3)

• Changes in exercise capacity

  Measured by peak oxygen consumption on cardiopulmonary exercise test

  Baseline, 3 months, 6 months

• Changes in left ventricular stroke volume

  Measured by echocardiography

  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).

  Baseline, 3 months, 6 months

Secondary Outcomes (9)

• Changes in left ventricular volume

  Baseline, 3 months, 6 months

• Changes in left atrial volume

  Baseline, 3 months, 6 months

• Changes in the measure of left ventricular mechanical dyssynchrony

  Baseline, 3 months, 6 months

• Changes in QRS complex width

  Baseline, 3 months, 6 months

• Changes in pacing thresholds

  Baseline, 3 months, 6 months

Study Arms (2)

His bundle pacing, AV optimized

EXPERIMENTAL

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

Backup VVI pacing

SHAM COMPARATOR

Pacemaker programmed to ventricular only pacing with low base rate (40/min) to allow intrinsic rhythm.

Device: Backup VVI pacing

Interventions

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.

His bundle pacing, AV optimized

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.

Backup VVI pacing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (12)

• 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.

  PMID: 29186415 BACKGROUND

• 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.

  PMID: 23677846 BACKGROUND

• 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.

  PMID: 10666756 BACKGROUND

• 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.

  PMID: 23801827 BACKGROUND

• 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.

  PMID: 12495391 BACKGROUND

• 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.

  PMID: 27855853 BACKGROUND

• 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.

  PMID: 25446158 BACKGROUND

• 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.

  PMID: 29535066 BACKGROUND

• 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.

  PMID: 19723701 BACKGROUND

• 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.

  PMID: 24963007 BACKGROUND

• 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.

  PMID: 25921348 BACKGROUND

• 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.

  PMID: 28575215 BACKGROUND

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 10, 2020
• Study Start: December 23, 2019
• Primary Completion: September 13, 2022
• Study Completion: January 4, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

SL (1)