Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block

NCT04624763 | Active Not Recruiting DMC

• 1 other identifier: FirstNanjingMU003
• Study Type: interventional
• Target: 683
• Locations: 1 country
• Sites: 1

Brief Summary

OptimPacing study has been designed as a prospective, multi-center, randomized, controlled trial. A total of 11 medical centers across China will enroll 683 patients over an estimated recruitment period of 2 years. An LBBP group will be compared with a group of conventional RVP in the follow-up of at least 3 years. The study aimed to demonstrate (1) the superiority of LBBP in preserving LV systolic function over RVP and (2) the feasibility and long-term safety of LBBP in patients with AV block.

Conditions

Atrioventricular Block

Keywords

Left bundle branch pacing; Atrioventricular block; Right ventricular pacing; Cardiac function

Outcome Measures

Primary Outcomes (4)

• A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

  Incidence of all-cause death, hospitalization for HF and/or PICM

  6-month follow-up

• A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

  Incidence of all-cause death, hospitalization for HF and/or PICM

  12-month follow-up

• A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

  Incidence of all-cause death, hospitalization for HF and/or PICM

  24-month follow-up

• A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)

  Incidence of all-cause death, hospitalization for HF and/or PICM

  36-month follow-up

Secondary Outcomes (13)

• Left ventricular ejection fraction(LVEF)

  Baseline; 6-month, 12-month, 24-month and 36-month follow-up

• Left ventricular end systolic volume(LVESV)

  Baseline; 6-month, 12-month, 24-month and 36-month follow-up

• Left ventricular end diastolic volume(LVEDV)

  Baseline; 6-month, 12-month, 24-month and 36-month follow-up

• Left ventricular end systolic diameter(LVESD)

  Baseline; 6-month, 12-month, 24-month and 36-month follow-up

• Left ventricular end diastolic diameter(LVEDD)

  Baseline; 6-month, 12-month, 24-month and 36-month follow-up

Study Arms (2)

LBBP group

EXPERIMENTAL

In this arm, a left bundle branch pacing(LBBP) lead is attempted to be placed.

Procedure: Left bundle branch pacing

RVP group

ACTIVE COMPARATOR

In this arm, a right ventricular pacing(RVP) lead are placed.

Procedure: Right ventricular pacing

Interventions

Left bundle branch pacing PROCEDURE

LBBP is defined if fulfilling criterion 1 and at least one in criteria 2: 1. Paced morphology of RBBD in surface lead V1 (QR, Qr, rSr', rSR' or Qrs); 2. One of the following should be met: 1. Selective LBBP with an iso-electrical window between the pacing spike and QRS onset; 2. If using dual-lead method with one at His-bundle and the other at LBB region, a retrograde His-bundle potential is recorded from His-bundle lead during LBBP; 3. LVATs at lead tip pacing of 1.5V/0.5ms and 10V/0.5ms are ≤ 80ms and the difference is \< 10ms; 4. A discrete LBB potential is recorded from lead tip and LVAT at tip pacing of 3V/0.5ms is ≤ 80ms19. If criterion 1 is fulfilled but none in criteria 2 is met, the procedure is considered to be left ventricular septal pacing (LVSP).

LBBP group

Right ventricular pacing PROCEDURE

Implantation of a RV pacing lead is attempted using the standard-of-care technique first.

RVP group

Eligibility Criteria

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

You may qualify if:

• Indication of permanent pacemaker implantation: (1) Second degree or complete AV block; (2) Persistent or permanent atrial fibrillation with mean ventricular rate \< 50 bpm and related symptoms
• LVEF \> 35%, NYHA classification I-III
• Age \> 18 years
• Signed informed consent

You may not qualify if:

• Implanted prosthetic tricuspid valve
• Unstable angina, acute myocardial infarction, CABG or PCI within the last 3 months
• Cardiac surgery like valvular replacement, TAVI, ventricular septal myectomy or ablation within the last 3 months
• Enrolled in any other study
• A life expectancy of less than 12 months or unable to undergo the planned 6. follow-up for any reasons
• Pregnant or with a child-bearing plan
• A history of heart transplantation
• Complex congenital heart disease (whether surgical correction or not) and post-surgery repair or post-closure of ventricular septal defect
• Ventricular septal hypertrophy (≥ 15mm during diastole)
• Isolated persistent left superior vena cava
• With ICD, CRT or CRTD indications
• Pacemaker replacement, upgrade and pocket infection needing re-implantation

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• West China Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Zhongshan Hospital Xiamen University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Fujian Medical University Union Hospital: collaborator
• Xijing Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Southwest Hospital, China: collaborator
• Beijing Chao Yang Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (19)

• Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.

  PMID: 12782566 BACKGROUND

• Khurshid S, Epstein AE, Verdino RJ, Lin D, Goldberg LR, Marchlinski FE, Frankel DS. Incidence and predictors of right ventricular pacing-induced cardiomyopathy. Heart Rhythm. 2014 Sep;11(9):1619-25. doi: 10.1016/j.hrthm.2014.05.040. Epub 2014 Jun 2.

  PMID: 24893122 BACKGROUND

• Funck RC, Blanc JJ, Mueller HH, Schade-Brittinger C, Bailleul C, Maisch B; BioPace Study Group. Biventricular stimulation to prevent cardiac desynchronization: rationale, design, and endpoints of the 'Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization (BioPace)' study. Europace. 2006 Aug;8(8):629-35. doi: 10.1093/europace/eul075.

  PMID: 16864616 BACKGROUND

• Ruschitzka F, Abraham WT, Singh JP, Bax JJ, Borer JS, Brugada J, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J; EchoCRT Study Group. Cardiac-resynchronization therapy in heart failure with a narrow QRS complex. N Engl J Med. 2013 Oct 10;369(15):1395-405. doi: 10.1056/NEJMoa1306687. Epub 2013 Sep 2.

  PMID: 23998714 BACKGROUND

• Deshmukh P, Casavant DA, Romanyshyn M, Anderson K. Permanent, direct His-bundle pacing: a novel approach to cardiac pacing in patients with normal His-Purkinje activation. Circulation. 2000 Feb 29;101(8):869-77. doi: 10.1161/01.cir.101.8.869.

  PMID: 10694526 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

• Vijayaraman P, Naperkowski A, Subzposh FA, Abdelrahman M, Sharma PS, Oren JW, Dandamudi G, Ellenbogen KA. Permanent His-bundle pacing: Long-term lead performance and clinical outcomes. Heart Rhythm. 2018 May;15(5):696-702. doi: 10.1016/j.hrthm.2017.12.022. Epub 2017 Dec 20.

  PMID: 29274474 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

• 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

• Vijayaraman P, Chung MK, Dandamudi G, Upadhyay GA, Krishnan K, Crossley G, Bova Campbell K, Lee BK, Refaat MM, Saksena S, Fisher JD, Lakkireddy D; ACC's Electrophysiology Council. His Bundle Pacing. J Am Coll Cardiol. 2018 Aug 21;72(8):927-947. doi: 10.1016/j.jacc.2018.06.017.

  PMID: 30115232 BACKGROUND

• Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.

  PMID: 29173611 BACKGROUND

• Hou X, Qian Z, Wang Y, Qiu Y, Chen X, Jiang H, Jiang Z, Wu H, Zhao Z, Zhou W, Zou J. Feasibility and cardiac synchrony of permanent left bundle branch pacing through the interventricular septum. Europace. 2019 Nov 1;21(11):1694-1702. doi: 10.1093/europace/euz188.

  PMID: 31322651 BACKGROUND

• Cai B, Huang X, Li L, Guo J, Chen S, Meng F, Wang H, Lin B, Su M. Evaluation of cardiac synchrony in left bundle branch pacing: Insights from echocardiographic research. J Cardiovasc Electrophysiol. 2020 Feb;31(2):560-569. doi: 10.1111/jce.14342. Epub 2020 Jan 20.

  PMID: 31919928 BACKGROUND

• Qian Z, Hou X, Wang Y, Jiang H, Wu H, Chen X, Wang B, Zou J. Physiological Left Bundle Branch Pacing Validated by Ultra-High Density Ventricular Mapping in a Swine Model. Circ Arrhythm Electrophysiol. 2020 Jan;13(1):e007898. doi: 10.1161/CIRCEP.119.007898. Epub 2020 Jan 14. No abstract available.

  PMID: 31935122 BACKGROUND

• Chen X, Jin Q, Li B, Jia J, Sharma PS, Huang W, Su Y, Ge J. Electrophysiological parameters and anatomical evaluation of left bundle branch pacing in an in vivo canine model. J Cardiovasc Electrophysiol. 2020 Jan;31(1):214-219. doi: 10.1111/jce.14300. Epub 2019 Dec 18.

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• Huang W, Wu S, Vijayaraman P, Su L, Chen X, Cai B, Zou J, Lan R, Fu G, Mao G, Ellenbogen KA, Whinnett ZI, Tung R. Cardiac Resynchronization Therapy in Patients With Nonischemic Cardiomyopathy Using Left Bundle Branch Pacing. JACC Clin Electrophysiol. 2020 Jul;6(7):849-858. doi: 10.1016/j.jacep.2020.04.011.

  PMID: 32703568 BACKGROUND

• Wang Y, Gu K, Qian Z, Hou X, Chen X, Qiu Y, Jiang Z, Zhang X, Wu H, Chen M, Zou J. The efficacy of left bundle branch area pacing compared with biventricular pacing in patients with heart failure: A matched case-control study. J Cardiovasc Electrophysiol. 2020 Aug;31(8):2068-2077. doi: 10.1111/jce.14628. Epub 2020 Jul 6.

  PMID: 32562442 BACKGROUND

• Li X, Qiu C, Xie R, Ma W, Wang Z, Li H, Wang H, Hua W, Zhang S, Yao Y, Fan X. Left bundle branch area pacing delivery of cardiac resynchronization therapy and comparison with biventricular pacing. ESC Heart Fail. 2020 Aug;7(4):1711-1722. doi: 10.1002/ehf2.12731. Epub 2020 May 13.

  PMID: 32400967 BACKGROUND

• Ponnusamy SS, Arora V, Namboodiri N, Kumar V, Kapoor A, Vijayaraman P. Left bundle branch pacing: A comprehensive review. J Cardiovasc Electrophysiol. 2020 Sep;31(9):2462-2473. doi: 10.1111/jce.14681. Epub 2020 Jul 30.

  PMID: 32681681 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 Officials

• Jiangang Zou

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 12, 2020
• Study Start: June 22, 2021
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)