Left Bundle Branch Pacing (LBBP) for the Treatment of Cardiac Dysfunction With Safety and Efficacy Study in Patients With Atrioventricular Block

Study Overview
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Brief Summary
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This study periodically assessed patients' cardiac function and prognosis by cardiac ultrasound, NYHA cardiac function class, 6-minute walk distance, quality of life score (QoL), and clinical events at follow-up, with the aim of assessing whether LBBP is no less effective than CRT in patients with left ventricular ejection fraction (LVEF) <50% and estimated percentage of ventricular pacing >40% of cardiac dysfunction.

Official Title
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Left Bundle Branch Pacing (LBBP) for the Treatment of Cardiac Dysfunction With Safety and Efficacy Study in Patients With Atrioventricular Block

Conditions
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Consented to Participate in the Trial and Signed an Informed Consent Form, NYHA Heart Function Classification of I-III

Intervention / Treatment
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* Device: LBBP/CRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age. Consent to participate in the trial and have signed an informed consent form. NYHA cardiac function classification of I-III. LVEF < 50%. Ventricular pacing-dependent patients with second-degree or complete AV block with pacing indications or ventricular pacing percentage >40%. Patients who are willing to implant a new implant or have their device replaced or upgraded. Exclusion Criteria: Life expectancy <1 year. Patients with severe tricuspid valve disease1 or who have undergone mechanical or bioprosthetic valve surgery. have had an acute myocardial infarction within 1 month Women of childbearing potential who are pregnant or who become pregnant during the study period. Severe hepatic or renal dysfunction. Have been enrolled in other clinical studies that may interfere with the objectives of this trial. Have evidence of severe pulmonary hypertension (PASP > 70 mmHg). Have evidence of hypertrophic cardiomyopathy that would affect the patient's prognosis. Subjects who, in the opinion of the investigator, are physically unfit to participate in this 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LBBP<br> | Device: LBBP/CRT<br>* The trial plans to enroll 160 patients with cardiac dysfunction who meet the enrollment criteria and agree to participate in the trial, and randomly assign them to the LBBP and CRT groups in a 1:1 ratio<br>|
| CRT<br> | Device: LBBP/CRT<br>* The trial plans to enroll 160 patients with cardiac dysfunction who meet the enrollment criteria and agree to participate in the trial, and randomly assign them to the LBBP and CRT groups in a 1:1 ratio<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 months of LVEF | LVEF at 12 months after implantation was analyzed to compare the LBBP treatment group with the CRT treatment group for the target subjects. | 12 months |