Left Bundle Branch Area Pacing in AVB Patients

Permanent Left Bundle Branch Area Pacing for Atrioventricular Block

Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony. His bundle pacing may restore the the atrioventricular, interventricular and intraventricular electrical synchronization, however, Increased pacing threshold might result in the early depletion of the pacemaker, and finally brought on pacemaker replacement, which was one of the major causes of device infection. Pacing the left bundle branch beyond the conduction block site might achieve a low and stable output and narrow QRSd. The investigators were prepared to consecutively include patients with atrioventricular block, divided into the left bundle branch area pacing(LBBAP) group and the conventional right ventricular pacing group. The electrophysiological characteristics of LBBAP and right ventricular pacing were compared with ECG characteristics. The left and right ventricular synchrony and left and right cardiac function were evaluated by 3D ultrasound, and the short-term and long-term safety and efficacy of LBBAP were evaluated.

Study Overview

• Status: Unknown
• Conditions: Atrioventricular Block; Left Bundle Branch Area Pacing
• Intervention / Treatment: Device: permanent left bundle branch area pacing

Detailed Description

This study is intended to be included in Fuwai hospital for admission to the atrioventricular block, with permanent pacemaker implant indications recommended by current guidelines. Patients were assessed for preoperative electrocardiogram, quality of life scores, cardiac function, and left and right ventricular synchrony. Patients were followed up by regular outpatients. The electrocardiogram, quality of life score, echocardiographic function, left and right ventricular synchrony, pacing parameters and pacing ratio were evaluated immediately after surgery, 3 months, 6 months, and 12 months after surgery. At the same time, the left bundle branch area pacing success rate, complications during intraoperative and postoperative follow-up were recorded.

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• China
  • Beijing
    • BeiJing, Beijing, China, 100037
      • Recruiting
      • Fu Wai Hospital
      • Contact: Xiaofei Li, Master; Phone Number: 17801013995; Email: lixiaofei0103@163.com
      • Contact: Xiaohan Fan, MD,PhD; Phone Number: 13811421067; Email: fanxiaohan@fuwaihospital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive AVB patients with indications for ventricular pacing according to 2013 ESC/EHRA Guidelines. Patients with persistent atrial fibrillation or indications for cardiac resynchronization therapy or implantable cardioverter defibrillator implantation , hypertrophic cardiomyopathy, myocardial amyloidosis, or refused postoperative follow-up were excluded. All patients should sign written informed consent for agreement of the implantation procedure.

Description

Inclusion Criteria:

1. Age over 18 years old;
2. Atrioventricular block patients with indication for permanent ventricular pacing;
3. LVEF> 40%;
4. With informed consent signed

Exclusion Criteria:

1. Persistent atrial fibrillation;
2. Moderate or more severe valvular disease;
3. Hypertrophic cardiomyopathy；
4. Myocardial amyloidosis；
5. With indication for CRT or ICD implantation according to the current guideline;
6. Poor condition of the acoustic window because of emphysema or other reasons;
7. Patients refused postoperative follow-up.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LBBAP group; patients received left bundle branch area pacing	Device: permanent left bundle branch area pacing; Implant the pacing lead in the left bundle branch area instead of traditional RV pacing site(septal or apical). Successful LBBAP was defined as the paced QRS morphology of right bundle branch block pattern in lead V1 and QRS duration (QRSd) less than 130ms.
traditional RVP group; Age and sex-matched patients received traditional right ventricular pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The synchronization status change at 3 months and 1 year as compared with baseline status.	Left ventricualr strain change from baseline to 3 month, from baselin to 1 year post operation.	3 months and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pacing threshold change at 3 months and 1 year as compared with baseline status.	The pacing threshold changes between 3-month and baseline status, changes between 1 year and the baseline status.	3 months and 1 year
LBBAP related adverse events at 3 months and 1 year as compared with baseline status.	The adverse events includes perforation, acute myocardial infarction, loss of capture, increase of pacing threshold, et al. These events were evaluated at baseline, 3 months and 1 year after the procedure, respectively.	3 months and 1 year
left ventricular ejection fraction change at 3 months and 1 year	Left ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.	3 months and 1 year
Right ventricular ejection fraction change at 3 months and 1 year	Right ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.	3 months and 1 year
Left ventricular end systolic diameter change at 3 months and 1 year	Left ventricular end systolic diameter change from baseline to 3 month, from baselin to 1 year post operation.	3 months and 1 year
Left ventricular end diastolic diameter change at 3 months and 1 year	Left ventricular end diastolic diameter change from baseline to 3 month, from baselin to 1 year post operation.	3 months and 1 year

Collaborators and Investigators

• Sponsor: Fu Wai Hospital, Beijing, China

Publications and helpful links

General Publications

• Vijayaraman P, Naperkowski A, Ellenbogen KA, Dandamudi G. Electrophysiologic Insights Into Site of Atrioventricular Block: Lessons From Permanent His Bundle Pacing. JACC Clin Electrophysiol. 2015 Dec;1(6):571-581. doi: 10.1016/j.jacep.2015.09.012. Epub 2015 Oct 17.
• 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.
• 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.
• Guo XG, Liu X, Zhou GB, Sun Q, Yang JD, Luo B, Ouyang F, Ma J, Zhang S. Clinical, electrocardiographic, and electrophysiological characteristics of left upper septal fascicular ventricular tachycardia. Europace. 2018 Apr 1;20(4):673-681. doi: 10.1093/europace/euw429.
• Upadhyay GA, Cherian T, Shatz DY, Beaser AD, Aziz Z, Ozcan C, Broman MT, Nayak HM, Tung R. Intracardiac Delineation of Septal Conduction in Left Bundle-Branch Block Patterns. Circulation. 2019 Apr 16;139(16):1876-1888. doi: 10.1161/CIRCULATIONAHA.118.038648.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: left bundle branch area pacing; Atrioventricular Block
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Atrioventricular Block
• Other Study ID Numbers: LBBAP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes