Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block)

NCT04730921 | Completed DMC FDA Device

• 1 other identifier: 2020-1379
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 8

Brief Summary

This is a multicenter, randomized controlled study. The aim of this study is to compare the impact of LBBAP on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular block.

Conditions

Atrioventricular Block; Left Bundle Branch Area Pacing; Right Ventricular Pacing; Heart Failure

Keywords

Atrioventricular Block; Left bundle branch area pacing; Right ventricular pacing

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the time to a first event of composite outcomes, including all-cause death, hospitalization for heart failure, and an upgrade to cardiac resynchronization therapy due to pacing induced heart failure.

  All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy. Upgrade to cardiac resynchronization therapy (CRT): Upgrade from dual-chamber pacemaker to CRT-Pacemaker/CRT-Defibrillator due to impaired LV function (LVEF decrease to 40% or less).

  Within two years after device implantation

Secondary Outcomes (11)

• Rate of the composite outcomes of all-cause death and/or hospitalization for heart failure

  Within 2 years after device implantation

• Rate of the composite outcomes of hospitalization for heart failure and/or an upgrade to cardiac resynchronization therapy due to pacing induced heart failure.

  Within 2 years after device implantation

• Rate of the composite outcomes of LVEF <50%, and/or an increase in LVESV ≥15% during follow-up as compared with the value at randomization

  Within 2 years after device implantation

• The value of LVEF and LVESV assessed by echocardiography at 1-year and 2-year follow-up

  24 months

• The time to a first event of LVEF <50% and decrease in LVEF by ≥ 10% during 2 years follow-up as compared with the value at randomization.

  24 months

Other Outcomes (2)

• Pre-existing heart disease based primary outcome

  Within 2 years after device implantation

• Baseline QRSd based primary outcome

  Within 2 years after device implantation

Study Arms (2)

LBBAP group

EXPERIMENTAL

AV block patients randomized to left bundle branch area pacing

Device: Left bundle branch area pacing

RVP group

ACTIVE COMPARATOR

AV block patients randomized to right ventricular pacing group

Device: Right ventricular pacing

Interventions

Left bundle branch area pacing DEVICE

Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration.

LBBAP group

Right ventricular pacing DEVICE

Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.

RVP group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. Adult patients aged 18-90;
• b. AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)\> 40%, including (a)Third-degree AV block; (b) Second degree AV block (type II); (c) intermittent advanced AV block with expected VP\>40%; (d)Symptomatic first degree AV block and PR interval on ECG ≥ 250ms;
• c. The subject is able to receive a pectoral implant;
• d. The subject is willing and able to comply with the protocol;
• e. The subject is expected to remain available for follow-up visits at the study centers.
• f. Subject or authorized legal guardian or representative has signed and dated the study Subject Informed Consent

You may not qualify if:

• a. Baseline echocardiographic assessment of patients with impaired LV function (LVEF\<50%);
• b. Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
• c. Patients with persistent atrial fibrillation;
• d. Pacemaker replacement without new implanted ventricular electrodes;
• e. Patients with implantable cardioverter-defibrillator (ICD) indications;
• f. Surgery is required within 1 year due to severe structural heart disease;
• g. Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc), or AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM)vpost (modified) Morrow surgery, (b) ventricular septal defect repair; and those who are unlikely to achieve successful LBBAP procedure.

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China: lead
• Beijing Anzhen Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• TEDA International Cardiovascular Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Chinese Society of Cardiology: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• Shanxi Cardiovascular Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Peking University First Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Wuxi People's Hospital: collaborator

Study Sites (8)

Beijing Anzhen hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450003, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Teda International Cardiovascular Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (10)

• Yu CM, Chan JY, Zhang Q, Omar R, Yip GW, Hussin A, Fang F, Lam KH, Chan HC, Fung JW. Biventricular pacing in patients with bradycardia and normal ejection fraction. N Engl J Med. 2009 Nov 26;361(22):2123-34. doi: 10.1056/NEJMoa0907555. Epub 2009 Nov 15.

  PMID: 19915220 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

• Cho SW, Gwag HB, Hwang JK, Chun KJ, Park KM, On YK, Kim JS, Park SJ. Clinical features, predictors, and long-term prognosis of pacing-induced cardiomyopathy. Eur J Heart Fail. 2019 May;21(5):643-651. doi: 10.1002/ejhf.1427. Epub 2019 Feb 8.

  PMID: 30734436 BACKGROUND

• Tayal B, Fruelund P, Sogaard P, Riahi S, Polcwiartek C, Atwater BD, Gislason G, Risum N, Torp-Pedersen C, Kober L, Kragholm KH. Incidence of heart failure after pacemaker implantation: a nationwide Danish Registry-based follow-up study. Eur Heart J. 2019 Nov 21;40(44):3641-3648. doi: 10.1093/eurheartj/ehz584.

  PMID: 31504437 BACKGROUND

• Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Mao G, Vijayaraman P, Ellenbogen KA. Long-term outcomes of His bundle pacing in patients with heart failure with left bundle branch block. Heart. 2019 Jan;105(2):137-143. doi: 10.1136/heartjnl-2018-313415. Epub 2018 Aug 9.

  PMID: 30093543 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

• Vijayaraman P, Dandamudi G. Anatomical approach to permanent His bundle pacing: Optimizing His bundle capture. J Electrocardiol. 2016 Sep-Oct;49(5):649-57. doi: 10.1016/j.jelectrocard.2016.07.003. Epub 2016 Jul 11.

  PMID: 27457727 BACKGROUND

• Li X, Li H, Ma W, Ning X, Liang E, Pang K, Yao Y, Hua W, Zhang S, Fan X. Permanent left bundle branch area pacing for atrioventricular block: Feasibility, safety, and acute effect. Heart Rhythm. 2019 Dec;16(12):1766-1773. doi: 10.1016/j.hrthm.2019.04.043. Epub 2019 Apr 29.

  PMID: 31048065 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

• 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

MeSH Terms

Conditions

Atrioventricular Block; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiaohan Fan, PhD.

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: November 13, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 1, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)