Left Bundle Branch Area Pacing in AVB Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Permanent Left Bundle Branch Area Pacing for Atrioventricular Block

Conditions
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Atrioventricular Block, Left Bundle Branch Area Pacing

Intervention / Treatment
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* Device: permanent left bundle branch area pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old; Atrioventricular block patients with indication for permanent ventricular pacing; LVEF> 40%; With informed consent signed Exclusion Criteria: Persistent atrial fibrillation; Moderate or more severe valvular disease; Hypertrophic cardiomyopathy； Myocardial amyloidosis； With indication for CRT or ICD implantation according to the current guideline; Poor condition of the acoustic window because of emphysema or other reasons; Patients refused postoperative follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LBBAP group<br>patients received left bundle branch area pacing | Device: permanent left bundle branch area pacing<br>* 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.<br>|
| traditional RVP group<br>Age and sex-matched patients received traditional right ventricular pacing | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrioventricular Block, left bundle branch area pacing