Clinical Efficacy and Safety of Left Bundle Branch Area Pacing Using Quantitative Guidance of Multimodal Data in the Treatment of Heart Failure

NCT07814612 | Recruiting DMC

• 1 other identifier: I-MRER[2024] No.(55)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure is a common chronic cardiovascular disease that seriously impairs patients' quality of life and long-term prognosis. When heart failure is complicated by complete left bundle branch block, the electrical signals that regulate orderly heart contraction cannot be transmitted normally along the left conduction pathway, causing the left and right ventricles to contract out of sync. This will gradually weaken the heart's pumping capacity, leading to symptoms such as exertional shortness of breath, persistent fatigue and body edema, and significantly increasing the risk of repeated hospital admissions and premature death. Traditional biventricular pacing is the standard treatment recommended by international clinical guidelines for this condition. By implanting pacing leads in both ventricles to deliver synchronized electrical stimulation, it restores cardiac synchrony, improves cardiac function and reduces mortality in most eligible patients. However, the placement of left ventricular leads is entirely dependent on the anatomy of the coronary venous system. Due to wide individual differences in venous structure, many patients encounter intraoperative difficulties such as failed coronary sinus intubation, absence of suitable target veins, phrenic nerve stimulation, high pacing thresholds and postoperative lead displacement. More importantly, approximately 30% to 40% of patients still show no significant improvement in cardiac function or symptoms even after optimized device programming, a condition known as non-response to cardiac resynchronization therapy. Left bundle branch area pacing is an innovative physiological pacing technique originally developed in China. It advances a pacing lead through the ventricular septum to directly activate the heart's intrinsic conduction bundle, allowing electrical impulses to spread along the natural conduction pathway and restore ventricular synchrony. Previous single-center observational studies have shown that this technique features stable long-term pacing parameters, relatively low operative difficulty and a favorable safety profile, and can achieve satisfactory cardiac resynchronization effects. Nevertheless, there is still a lack of high-quality multicenter randomized controlled evidence to confirm its long-term clinical hard endpoint benefits. In addition, current implantation operations largely rely on the personal experience of operators, without a unified quantitative positioning standard. This multicenter prospective randomized controlled study is led by the Second Affiliated Hospital of Nanchang University, with three other tertiary general hospitals participating. A total of 100 eligible heart failure patients with left bundle branch block and left ventricular ejection fraction ≤ 40% will be enrolled. All participants have received at least 3 months of standardized guideline-directed anti-heart failure drug therapy before enrollment, and will be randomly assigned to two groups at a 1:1 ratio. One group will receive left bundle branch area pacing guided by multimodal quantitative data, and the other will receive traditional biventricular pacing. If the initially assigned pacing strategy cannot be successfully implemented during surgery, the patient will cross over to the alternative approach to ensure clinical safety and therapeutic effect. After the implantation procedure, all patients will receive regular follow-up every 3 months for at least 1 year. During follow-up, the research team will perform examinations including 12-lead electrocardiogram, echocardiogram, 6-minute walk test and pacemaker device interrogation, and systematically record clinical events such as all-cause death, heart failure rehospitalization, malignant arrhythmia and procedure-related complications. The core goal of this study is to compare the incidence of the composite endpoint of all-cause death and heart failure rehospitalization between the two groups, and verify whether multimodal quantitative-guided left bundle branch area pacing can bring superior long-term clinical benefits to heart failure patients. The findings are expected to provide reliable evidence for the clinical application of this technique, help establish standardized quantitative implantation standards, and offer a more optimized treatment option for more heart failure patients.

Conditions

Heart Failure; Left Bundle Branch Block; Non-ischemic Cardiomyopathy

Keywords

Left bundle branch area pacing; Biventricular pacing; Heart failure; Multimodal data; Complete left bundle branch block

Outcome Measures

Primary Outcomes (1)

• Incidence of composite endpoint of all-cause mortality and/or heart failure rehospitalization

  This is the primary endpoint of the study. The composite endpoint consists of all-cause mortality and/or heart failure rehospitalization (HFH). HFH is defined as worsening of heart failure symptoms and signs in outpatient, emergency or inpatient settings, requiring oral or intravenous diuretics to relieve clinical symptoms. The incidence of the composite endpoint during follow-up is compared between the two study arms to evaluate the difference in clinical efficacy.

  Postoperative follow-up is conducted every 3 months for a total of one year.

Secondary Outcomes (4)

• Incidence of all-cause mortality during study follow-up

  Postoperative follow-up is conducted every 3 months for a total of one year.

• Incidence of heart failure rehospitalization during study follow-up

  Postoperative follow-up is conducted every 3 months for a total of one year.

• Incidence of malignant ventricular arrhythmia during study follow-up

  Postoperative follow-up is conducted every 3 months for a total of one year.

• Incidence of procedure-related complications

  Postoperative follow-up is conducted every 3 months for a total of one year.

Study Arms (2)

Left bundle branch area pacing (LBBAP) group

EXPERIMENTAL

Participants are randomly assigned to this arm at a 1:1 ratio. Eligible subjects are patients aged 18-80 years with sinus rhythm, complete left bundle branch block (Strauss criteria: QRS \>140 ms in males, QRS \>130 ms in females), non-ischemic cardiomyopathy, left ventricular ejection fraction ≤40%, NYHA functional class Ⅱ-Ⅳ, and who have received at least 3 months of guideline-directed medical therapy for heart failure. Subjects in this arm receive left bundle branch area pacing quantitatively guided by multimodal data fusion. If no evidence of left bundle branch capture is achieved intraoperatively, LBBP is defined as failed and participants will cross over to the biventricular pacing arm. All subjects undergo follow-up every 3 months after surgery for at least 1 year.

Procedure: Apply multimodal data fusion for quantitative guidance of left bundle branch region pacing

Biventricular pacing (BiVP) group

ACTIVE COMPARATOR

Participants are randomly assigned to this arm at a 1:1 ratio. Eligible subjects are patients aged 18-80 years with sinus rhythm, complete left bundle branch block (Strauss criteria), non-ischemic cardiomyopathy, LVEF ≤40%, NYHA class Ⅱ-Ⅳ, and at least 3 months of guideline-directed heart failure medical therapy. Subjects receive conventional biventricular pacing via coronary sinus lead implantation, with retrograde venography to select lateral or posterolateral target veins. If left ventricular lead implantation fails or phrenic nerve stimulation occurs, participants will cross over to the LBBAP arm. Postoperatively, devices are programmed to DDD mode with optimized intervals, and all subjects undergo standardized follow-up every 3 months for at least 1 year.

Procedure: Conventional Biventricular Pacing

Interventions

Apply multimodal data fusion for quantitative guidance of left bundle branch region pacing PROCEDURE

This intervention adopts the trans-septal approach. A 3830 active fixation lead is delivered via a C315 delivery sheath under 30° right anterior oblique fluoroscopy to the right ventricular septal side. The implantation site is guided by multimodal data fusion, including imaging distance parameters and intraoperative pacing electrocardiographic indicators. The lead is screwed into the deep interventricular septum to reach the left ventricular subendocardial region, with paced QRS in lead V1 presenting right bundle branch block morphology to correct baseline left bundle branch block. Sensing function, pacing thresholds and pacing impedance are tested intraoperatively, and left ventricular activation time is measured to confirm left bundle branch capture. If LBBP is not achieved after 5 site attempts, participants will cross over to the biventricular pacing arm. Postoperatively, devices are programmed to DDD mode with optimized AV intervals to achieve the narrowest paced QRS duration.

Left bundle branch area pacing (LBBAP) group

Conventional Biventricular Pacing PROCEDURE

This intervention delivers standard cardiac resynchronization therapy via the coronary sinus approach to correct left bundle branch block and restore biventricular electromechanical synchrony. Retrograde coronary venography is performed intraoperatively to visualize the coronary sinus trunk and its branch vessels, and the lateral or posterolateral vein is selected as the target for left ventricular lead implantation. For defibrillator devices, the defibrillation lead is implanted in the right ventricular outflow tract septum or apex. If no target vein is available, implantation fails, pacing threshold is excessively high, or phrenic nerve stimulation occurs, participants will cross over to the LBBAP arm. For patients with quadripolar left ventricular leads, pacing vectors are selected based on pacing threshold and paced QRS width. Postoperatively, devices are programmed to DDD mode with optimized AV and VV intervals to maintain a biventricular pacing proportion above 92%.

Biventricular pacing (BiVP) group

Eligibility Criteria

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

You may qualify if:

• Age 18-80 years;
• Sinus rhythm, complete left bundle branch block (LBBB) fulfilling the Strauss criteria (QRS duration \>140 ms in men or \>130 ms in women);
• Non-ischemic cardiomyopathy, left ventricular ejection fraction (LVEF) ≤40%, and New York Heart Association (NYHA) functional class II-IV;
• Signed informed consent.
• All enrolled patients received guideline-recommended pharmacological therapy for heart failure for at least 3 months.

You may not qualify if:

• Coronary CT-confirmed ischemic cardiomyopathy;
• wide QRS complex with non-LBBB morphology, including right bundle branch block and nonspecific intraventricular conduction block;
• persistent atrial fibrillation;
• pacemaker replacement without reimplantation of ventricular leads;
• patients with special conditions, such as pregnancy, gestation, and advanced malignancy.
• All patients underwent detailed recording of electrophysiological pacing parameters intraoperatively and postoperatively, and monitoring for surgical complications.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator
• Chifeng Municipal Hospital: collaborator
• Hohhot First Hospital, Hohhot, Inner Mongolia, China: collaborator

Study Sites (1)

Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.

Nanchang, Jiangxi, 330006, China

RECRUITING

Related Publications (55)

• Hu X, Qian Z, Zou F, Xue S, Zhang X, Wang Y, Hou X, Zhou W, Zou J. A Mild Dyssynchronous Contraction Pattern Detected by SPECT Myocardial Perfusion Imaging Predicts Super-Response to Cardiac Resynchronization Therapy. Front Cardiovasc Med. 2022 May 31;9:906467. doi: 10.3389/fcvm.2022.906467. eCollection 2022.

  PMID: 35711371 RESULT

• Cleland JGF, Bristow MR, Freemantle N, Olshansky B, Gras D, Saxon L, Tavazzi L, Boehmer J, Ghio S, Feldman AM, Daubert JC, de Mets D. The effect of cardiac resynchronization without a defibrillator on morbidity and mortality: an individual patient data meta-analysis of COMPANION and CARE-HF. Eur J Heart Fail. 2022 Jun;24(6):1080-1090. doi: 10.1002/ejhf.2524. Epub 2022 May 22.

  PMID: 35490339 RESULT

• Chen Y, Xue X, Gu Y, Xu H, Zhang X. Equilibrium radionuclide angiography compared with tissue doppler imaging for detection of right ventricular dyssynchrony and prediction of acute response to cardiac resynchronization therapy. Medicine (Baltimore). 2020 Feb;99(9):e19296. doi: 10.1097/MD.0000000000019296.

  PMID: 32118744 RESULT

• Moscoso I, Cebro-Marquez M, Martinez-Gomez A, Abou-Jokh C, Martinez-Monzonis MA, Martinez-Sande JL, Gonzalez-Melchor L, Garcia-Seara J, Fernandez-Lopez XA, Morana-Fernandez S, Gonzalez-Juanatey JR, Rodriguez-Manero M, Lage R. Circulating miR-499a and miR-125b as Potential Predictors of Left Ventricular Ejection Fraction Improvement after Cardiac Resynchronization Therapy. Cells. 2022 Jan 13;11(2):271. doi: 10.3390/cells11020271.

  PMID: 35053387 RESULT

• Kaddour M, Kozhuharov N, Burri H. Case report of hidden (yet visible) systolic fascicular potentials in a patient with left bundle branch block during conduction system pacing implantation. Eur Heart J Case Rep. 2023 Jan 14;7(1):ytad024. doi: 10.1093/ehjcr/ytad024. eCollection 2023 Jan.

  PMID: 36727139 RESULT

• Zaidi SMJ, Sohail H, Satti DI, Sami A, Anwar M, Malik J, Mustafa B, Mustafa M, Mehmoodi A. Tricuspid regurgitation in His bundle pacing: A systematic review. Ann Noninvasive Electrocardiol. 2022 Nov;27(6):e12986. doi: 10.1111/anec.12986. Epub 2022 Jun 28.

  PMID: 35763445 RESULT

• Samy M, Hamdy RM. A case report of balloon-assisted tracking to overcome coronary sinus competent valve: a novel technique in left ventricular lead implantation. Eur Heart J Case Rep. 2022 Feb 2;6(2):ytac056. doi: 10.1093/ehjcr/ytac056. eCollection 2022 Feb.

  PMID: 35169680 RESULT

• Verzaal NJ, van Deursen CJM, Pezzuto S, Wecke L, van Everdingen WM, Vernooy K, Delhaas T, Auricchio A, Prinzen FW. Synchronization of repolarization after cardiac resynchronization therapy: A combined clinical and modeling study. J Cardiovasc Electrophysiol. 2022 Aug;33(8):1837-1846. doi: 10.1111/jce.15581. Epub 2022 Jun 11.

  PMID: 35662306 RESULT

• Yamada S, Kaneshiro T, Yoshihisa A, Nodera M, Amami K, Nehashi T, Takeishi Y. Albumin-Bilirubin Score for Prediction of Outcomes in Heart Failure Patients Treated with Cardiac Resynchronization Therapy. J Clin Med. 2021 Nov 18;10(22):5378. doi: 10.3390/jcm10225378.

  PMID: 34830658 RESULT

• Chen HC, Liu WH, Tseng CH, Chen YL, Lee WC, Fang YN, Chong SZ, Chen MC. Diabetes Increases Risk of Cardiovascular Events in Patients Receiving Permanent Pacemaker: A Propensity Score-Matched Cohort Study. J Diabetes Res. 2022 Mar 28;2022:6758297. doi: 10.1155/2022/6758297. eCollection 2022.

  PMID: 35386265 RESULT

• Liang Y, Wang J, Gong X, Lu H, Yu Z, Zhang L, Li M, Pan L, Chen X, Cui J, Zhang W, Li R, Zhou X, Huang W, Su Y, Ge J. Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e011181. doi: 10.1161/CIRCEP.122.011181. Epub 2022 Oct 28.

  PMID: 36306335 RESULT

• Baumgartner T, Kaelin-Friedrich M, Makowski K, Noti F, Schaer B, Haeberlin A, Badertscher P, Kozhuharov N, Baldinger S, Seiler J, Osswald S, Kuhne M, Roten L, Tanner H, Sticherling C, Reichlin T. Sex-Related Differences in Patient Selection for and Outcomes after Pace and Ablate for Refractory Atrial Fibrillation: Insights from a Large Multicenter Cohort. J Clin Med. 2022 Aug 22;11(16):4927. doi: 10.3390/jcm11164927.

  PMID: 36013164 RESULT

• Lapidot D, Rav-Acha M, Bdolah-Abram T, Farkash R, Glikson M, Hasin T. QRS Narrowing Following CRT Implantation: Predictors, Dynamics, and Association with Improved Long-Term Outcome. J Clin Med. 2022 Feb 26;11(5):1279. doi: 10.3390/jcm11051279.

  PMID: 35268370 RESULT

• Owashi K, Taconne M, Courtial N, Simon A, Garreau M, Hernandez A, Donal E, Le Rolle V, Galli E. Desynchronization Strain Patterns and Contractility in Left Bundle Branch Block through Computer Model Simulation. J Cardiovasc Dev Dis. 2022 Feb 6;9(2):53. doi: 10.3390/jcdd9020053.

  PMID: 35200706 RESULT

• Li X, Zhang J, Qiu C, Wang Z, Li H, Pang K, Yao Y, Liu Z, Xie R, Chen Y, Wu Y, Fan X. Clinical Outcomes in Patients With Left Bundle Branch Area Pacing vs. Right Ventricular Pacing for Atrioventricular Block. Front Cardiovasc Med. 2021 Jul 8;8:685253. doi: 10.3389/fcvm.2021.685253. eCollection 2021.

  PMID: 34307499 RESULT

• Burri H, Jastrzebski M, Cano O, Curila K, de Pooter J, Huang W, Israel C, Joza J, Romero J, Vernooy K, Vijayaraman P, Whinnett Z, Zanon F. EHRA clinical consensus statement on conduction system pacing implantation: endorsed by the Asia Pacific Heart Rhythm Society (APHRS), Canadian Heart Rhythm Society (CHRS), and Latin American Heart Rhythm Society (LAHRS). Europace. 2023 Apr 15;25(4):1208-1236. doi: 10.1093/europace/euad043.

  PMID: 37061848 RESULT

• Arnold AD, Shun-Shin MJ, Keene D, Howard JP, Sohaib SMA, Wright IJ, Cole GD, Qureshi NA, Lefroy DC, Koa-Wing M, Linton NWF, Lim PB, Peters NS, Davies DW, Muthumala A, Tanner M, Ellenbogen KA, Kanagaratnam P, Francis DP, Whinnett ZI. His Resynchronization Versus Biventricular Pacing in Patients With Heart Failure and Left Bundle Branch Block. J Am Coll Cardiol. 2018 Dec 18;72(24):3112-3122. doi: 10.1016/j.jacc.2018.09.073.

  PMID: 30545450 RESULT

• de Vere F, Wijesuriya N, Howell S, Elliott MK, Mehta V, Mannakkara NN, Strocchi M, Niederer SA, Rinaldi CA. Optimizing outcomes from cardiac resynchronization therapy: what do recent data and insights say? Expert Rev Cardiovasc Ther. 2024 Dec 25;22(12):1-18. doi: 10.1080/14779072.2024.2445246. Online ahead of print.

  PMID: 39695920 RESULT

• Whinnett ZI, Shun-Shin MJ, Tanner M, Foley P, Chandrasekaran B, Moore P, Adhya S, Qureshi N, Muthumala A, Lane R, Rinaldi A, Agarwal S, Leyva F, Behar J, Bassi S, Ng A, Scott P, Prasad R, Swinburn J, Tomson J, Sethi A, Shah J, Lim PB, Kyriacou A, Thomas D, Chuen J, Kamdar R, Kanagaratnam P, Mariveles M, Burden L, March K, Howard JP, Arnold A, Vijayaraman P, Stegemann B, Johnson N, Falaschetti E, Francis DP, Cleland JGF, Keene D. Effects of haemodynamically atrio-ventricular optimized His bundle pacing on heart failure symptoms and exercise capacity: the His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) randomized, double-blind, cross-over trial. Eur J Heart Fail. 2023 Feb;25(2):274-283. doi: 10.1002/ejhf.2736.

  PMID: 36404397 RESULT

• Liu P, Wang Q, Sun H, Qin X, Zheng Q. Left Bundle Branch Pacing: Current Knowledge and Future Prospects. Front Cardiovasc Med. 2021 Mar 23;8:630399. doi: 10.3389/fcvm.2021.630399. eCollection 2021.

  PMID: 33834042 RESULT

• Chen X, Ye Y, Wang Z, Jin Q, Qiu Z, Wang J, Qin S, Bai J, Wang W, Liang Y, Chen H, Sheng X, Gao F, Zhao X, Fu G, Ellenbogen KA, Su Y, Ge J. Cardiac resynchronization therapy via left bundle branch pacing vs. optimized biventricular pacing with adaptive algorithm in heart failure with left bundle branch block: a prospective, multi-centre, observational study. Europace. 2022 May 3;24(5):807-816. doi: 10.1093/europace/euab249.

  PMID: 34718539 RESULT

• Sirinvaravong N, Heimann M, Liskov S, Yan GX. Dual atrial rhythms: a case report of an unusual cause of pacemaker syndrome. Eur Heart J Case Rep. 2022 Jan 9;6(1):ytab531. doi: 10.1093/ehjcr/ytab531. eCollection 2022 Jan.

  PMID: 35059558 RESULT

• 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 RESULT

• Yoshiyama T, Shimeno K, Hayashi Y, Ito A, Iwata S, Matsumura Y, Izumiya Y, Abe Y, Ehara S, Naruko T. Risk factors of pacing-induced cardiomyopathy-Insights from lead position. J Arrhythm. 2022 Apr 7;38(3):408-415. doi: 10.1002/joa3.12712. eCollection 2022 Jun.

  PMID: 35785399 RESULT

• Bozorgi A. Left Bundle Branch Pacing. J Tehran Heart Cent. 2022 Oct;17(4):165-167. doi: 10.18502/jthc.v17i4.11602. No abstract available.

  PMID: 37143754 RESULT

• Liu X, Niu HX, Gu M, Chen X, Hu Y, Cai M, Zhang N, Zhao J, Zhou X, Gold MR, Hua W, Zhang S. Contrast-enhanced image-guided lead deployment for left bundle branch pacing. Heart Rhythm. 2021 Aug;18(8):1318-1325. doi: 10.1016/j.hrthm.2021.04.015. Epub 2021 Apr 19.

  PMID: 33887449 RESULT

• Jiang H, Hou X, Qian Z, Wang Y, Tang L, Qiu Y, Jiang Z, Chen X, Li K, Zou J. A novel 9-partition method using fluoroscopic images for guiding left bundle branch pacing. Heart Rhythm. 2020 Oct;17(10):1759-1767. doi: 10.1016/j.hrthm.2020.05.018. Epub 2020 May 15.

  PMID: 32417259 RESULT

• Zhang J, Wang Z, Zu L, Cheng L, Su R, Wang X, Liang Z, Chen J, Hang F, Du J, Huang W, Wu Y. Simplifying Physiological Left Bundle Branch Area Pacing Using a New Nine-Partition Method. Can J Cardiol. 2021 Feb;37(2):329-338. doi: 10.1016/j.cjca.2020.05.011. Epub 2020 May 16.

  PMID: 32428620 RESULT

• Zhang JM, Zhang YX, Chen JR, Wang ZF, Zu LN, Cheng LT, Wang ZY, Wang XL, Hang F, Wu YQ. [Feasibility and safety of new simplified left bundle branch area pacing via nine-partition method]. Zhonghua Xin Xue Guan Bing Za Zhi. 2020 Oct 24;48(10):848-852. doi: 10.3760/cma.j.cn112148-20200520-00414. Chinese.

  PMID: 33076622 RESULT

• Lu W, Lin J, Chen K, Dai Y, Chen R, Hu Q, Li Y, Cheng C, Zhou Y, Zhang S. Quantitative distance and electrocardiographic parameters for lead-implanted site selection to enhance the success likelihood of left bundle branch pacing. Clin Res Cardiol. 2022 Nov;111(11):1219-1230. doi: 10.1007/s00392-021-01965-1. Epub 2021 Nov 11.

  PMID: 34761309 RESULT

• Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.

  PMID: 31233818 RESULT

• Zweerink A, Burri H. His-Optimized and Left Bundle Branch-Optimized Cardiac Resynchronization Therapy: In Control of Fusion Pacing. Card Electrophysiol Clin. 2022 Jun;14(2):311-321. doi: 10.1016/j.ccep.2021.12.006. Epub 2022 May 23.

  PMID: 35715088 RESULT

• Jastrzebski M. Physiologic Differentiation Between Selective His Bundle, Nonselective His Bundle and Septal Pacing. Card Electrophysiol Clin. 2022 Jun;14(2):151-163. doi: 10.1016/j.ccep.2021.12.009. Epub 2022 May 25.

  PMID: 35715074 RESULT

• Jastrzebski M, Moskal P, Huybrechts W, Curila K, Sreekumar P, Rademakers LM, Ponnusamy SS, Herweg B, Sharma PS, Bednarek A, Rajzer M, Vijayaraman P. Left bundle branch-optimized cardiac resynchronization therapy (LOT-CRT): Results from an international LBBAP collaborative study group. Heart Rhythm. 2022 Jan;19(1):13-21. doi: 10.1016/j.hrthm.2021.07.057. Epub 2021 Jul 30.

  PMID: 34339851 RESULT

• Sharma PS, Patel NR, Ravi V, Zalavadia DV, Dommaraju S, Garg V, Larsen TR, Naperkowski AM, Wasserlauf J, Krishnan K, Young W, Pokharel P, Oren JW, Storm RH, Trohman RG, Huang HD, Subzposh FA, Vijayaraman P. Clinical outcomes of left bundle branch area pacing compared to right ventricular pacing: Results from the Geisinger-Rush Conduction System Pacing Registry. Heart Rhythm. 2022 Jan;19(1):3-11. doi: 10.1016/j.hrthm.2021.08.033. Epub 2021 Sep 3.

  PMID: 34481985 RESULT

• Clementy N, Bodin A, Ah-Fat V, Babuty D, Bisson A. Dual-chamber ICD for left bundle branch area pacing: the cardiac resynchronization and arrhythmia sensing via the left bundle (cross-left) pilot study. J Interv Card Electrophysiol. 2023 Jun;66(4):905-912. doi: 10.1007/s10840-022-01342-6. Epub 2022 Aug 16.

  PMID: 35970951 RESULT

• Li Y, Yan L, Dai Y, Zhou Y, Sun Q, Chen R, Lin J, Jin Y, Chen F, Guo X, Chen K, Zhang S. Feasibility and efficacy of left bundle branch area pacing in patients indicated for cardiac resynchronization therapy. Europace. 2020 Dec 26;22(Suppl_2):ii54-ii60. doi: 10.1093/europace/euaa271.

  PMID: 33370801 RESULT

• 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 RESULT

• 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 RESULT

• Zhang W, Huang J, Qi Y, Wang F, Guo L, Shi X, Wu W, Zhou X, Li R. Cardiac resynchronization therapy by left bundle branch area pacing in patients with heart failure and left bundle branch block. Heart Rhythm. 2019 Dec;16(12):1783-1790. doi: 10.1016/j.hrthm.2019.09.006. Epub 2019 Sep 9.

  PMID: 31513945 RESULT

• Vijayaraman P, Subzposh FA, Naperkowski A, Panikkath R, John K, Mascarenhas V, Bauch TD, Huang W. Prospective evaluation of feasibility and electrophysiologic and echocardiographic characteristics of left bundle branch area pacing. Heart Rhythm. 2019 Dec;16(12):1774-1782. doi: 10.1016/j.hrthm.2019.05.011. Epub 2019 May 25.

  PMID: 31136869 RESULT

• 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 RESULT

• Chen K, Li Y, Dai Y, Sun Q, Luo B, Li C, Zhang S. Comparison of electrocardiogram characteristics and pacing parameters between left bundle branch pacing and right ventricular pacing in patients receiving pacemaker therapy. Europace. 2019 Apr 1;21(4):673-680. doi: 10.1093/europace/euy252.

  PMID: 30462207 RESULT

• 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 RESULT

• Scheetz SD, Upadhyay GA. Physiologic Pacing Targeting the His Bundle and Left Bundle Branch: a Review of the Literature. Curr Cardiol Rep. 2022 Aug;24(8):959-978. doi: 10.1007/s11886-022-01723-3. Epub 2022 Jun 9.

  PMID: 35678938 RESULT

• Zanon F, Marcantoni L, Centioni M, Pastore G, Baracca E. His Bundle Pacing: My Experience, Tricks, and Tips. Card Electrophysiol Clin. 2022 Jun;14(2):141-149. doi: 10.1016/j.ccep.2021.12.016.

  PMID: 35715073 RESULT

• Israel CW, Tribunyan S, Kalyani M. His bundle pacing: troubleshooting at implantation. Herzschrittmacherther Elektrophysiol. 2020 Jun;31(2):160-176. doi: 10.1007/s00399-020-00690-y.

  PMID: 32399642 RESULT

• Vinther M, Risum N, Svendsen JH, Mogelvang R, Philbert BT. A Randomized Trial of His Pacing Versus Biventricular Pacing in Symptomatic HF Patients With Left Bundle Branch Block (His-Alternative). JACC Clin Electrophysiol. 2021 Nov;7(11):1422-1432. doi: 10.1016/j.jacep.2021.04.003. Epub 2021 Apr 25.

  PMID: 34167929 RESULT

• Ajijola OA, Upadhyay GA, Macias C, Shivkumar K, Tung R. Permanent His-bundle pacing for cardiac resynchronization therapy: Initial feasibility study in lieu of left ventricular lead. Heart Rhythm. 2017 Sep;14(9):1353-1361. doi: 10.1016/j.hrthm.2017.04.003. Epub 2017 Apr 8.

  PMID: 28400315 RESULT

• Upadhyay GA, Vijayaraman P, Nayak HM, Verma N, Dandamudi G, Sharma PS, Saleem M, Mandrola J, Genovese D, Oren JW, Subzposh FA, Aziz Z, Beaser A, Shatz D, Besser S, Lang RM, Trohman RG, Knight BP, Tung R; His-SYNC Investigators. On-treatment comparison between corrective His bundle pacing and biventricular pacing for cardiac resynchronization: A secondary analysis of the His-SYNC Pilot Trial. Heart Rhythm. 2019 Dec;16(12):1797-1807. doi: 10.1016/j.hrthm.2019.05.009. Epub 2019 May 13.

  PMID: 31096064 RESULT

• Archontakis S, Sideris K, Laina A, Arsenos P, Paraskevopoulou D, Tyrovola D, Gatzoulis K, Tousoulis D, Tsioufis K, Sideris S. His bundle pacing: A promising alternative strategy for anti-bradycardic pacing - report of a single-center experience. Hellenic J Cardiol. 2022 Mar-Apr;64:77-86. doi: 10.1016/j.hjc.2021.10.005. Epub 2021 Nov 27.

  PMID: 34843996 RESULT

• Richter S. Permanent His bundle pacing: adopt, adapt, and improve. Europace. 2022 Apr 5;24(4):530-532. doi: 10.1093/europace/euab325. No abstract available.

  PMID: 35152288 RESULT

• Hanley A, Singh JP. His Bundle Pacing: Are We There Yet? JACC Clin Electrophysiol. 2022 Jan;8(1):70-72. doi: 10.1016/j.jacep.2021.08.014. No abstract available.

  PMID: 35057980 RESULT

• Pastore G, Zanon F, Baracca E, Aggio S, Corbucci G, Boaretto G, Roncon L, Noventa F, Barold SS. The risk of atrial fibrillation during right ventricular pacing. Europace. 2016 Mar;18(3):353-8. doi: 10.1093/europace/euv268. Epub 2015 Oct 5.

  PMID: 26443444 RESULT

• WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.

  PMID: 23741058 RESULT

Related Links

• Related Info
• Related Info
• Related Info

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhenyu Zhai, PHD

CONTACT

+86 15079109953; 13337107502@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: September 11, 2026
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)