Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block

Study Overview
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Brief Summary
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This study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with LVEF <50% and the estimated ventricular pacing percentage >40% with LBBP have the non-inferior safety and efficacy than CRT on patients' cardiac function and prognosis

Detailed Description
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Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, patients with cardiac dysfunction who met the enrollment criteria and will agree to participate in this trial will be 1:1 randomized to the LBBP group and the CRT group. Patients who were successfully implanted were enrolled for evaluation and follow-up. The primary end points of the study is the change of LVEF within 12 months post-implant in both LBBP Treatment Group and CRT Treatment Group

Official Title
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Safety and Effectiveness of Left Bundle Branch Pacing (LBBP) in Patients With Cardiac Dysfunction and AV Block

Conditions
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Atrioventricular Block, Second and Third Degree, Heart Failure, Left Bundle Branch Pacing

Intervention / Treatment
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* Device: Left bundle branch pacing
* Device: Bi-ventricular pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above 18 years old Agree to participate in trial and sign informed consent NYHA cardiac function class I-III LVEF<50% Second or complete atrioventricular block with pacing indication or ventricular pacing dependent with ventricular pacing percentage >40% Patients who are willing to take the de-novo implant or device replacement or upgrade. Exclusion Criteria: Life expectancy <1 year Patients with severe tricuspid valvular disease1 or who have undergone mechanical valve or bioprosthetic valve surgery Acute myocardial infarction within 1 month Women of childbearing age who are pregnant or becoming pregnant during the study period Severe liver and kidney dysfunction2 Have been enrolled in another clinical studies that may interferes with the current trial objectives Evidence of severe pulmonary hypertension (PASP>70mmHg) Evidence of hypertrophic cardiomyopathy which shall affect the prognosis of patients. The investigator believes that subject's physical condition is not suitable for participation in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBBP Treatment<br>Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device | Device: Left bundle branch pacing<br>* Left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device through the pacing lead at left bundle branch region<br>Device: Bi-ventricular pacing<br>* Bi-ventricular pacing by a CRT/CRTD device<br>|
| Active Comparator: BVP Treatment<br>Patients were performed bi-ventricular pacing by a CRT/CRTD device | Device: Left bundle branch pacing<br>* Left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device through the pacing lead at left bundle branch region<br>Device: Bi-ventricular pacing<br>* Bi-ventricular pacing by a CRT/CRTD device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of LVEF | To compare the effects of LBBP Treatment Group and CRT Treatment Group on target subjects by analyzing the LVEF within 12 months post-implant. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of LVESV | To demonstrate and compare the LVESV at 12 month post-implant. | 12 months | 
| successful rate | To characterize the successful rate of LBBP Procedure and CRT Procedure among randomized patients' group. | 12 months | 
| mortality and heart failure hospitalization rate | To demonstrate and compare the mortality and heart failure hospitalization rate between LBBP and CRT treatment group 12 month post-implant | 12 months | 
| occurrence of serious complication associated with LBBP procedure | To characterize occurrence of serious complication associated with LBBP procedure within 12 month post-implant. | 12 months | 
| QRS width between LBBP and CRT | To characterize and compare the QRS width between LBBP and CRT treatment groups during the baseline, preoperative, postoperative and follow up visits within 3 months and 12 month post-implant. | 12 months | 
| incidence and severity of tricuspid regurgitation | To assess and compare the incidence and severity of tricuspid regurgitation between LBBP and CRT treatment groups within 12 month post-implant | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacing induced cardiomyopathy, heart failure, pacing, LBBP, BVP, RVP, conduction system pacing, cardiac Resynchronization Therapy, bradycardiac arrhythmia