Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block

AVB - Atrioventricular Block Clinical Trial

Official title:

Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block: an Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722379
• Other study ID #: WestChinaH-LBBP-001
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2023
• Source: West China Hospital
• Contact: Zhongxiu Chen, Dr
• Phone: 18030708238
• Email: 619087296[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. In this study, the investigators aim to conduct a comparison of the safety and effectiveness performance between these two pacing methods for patients with atrioventricular block (AVB). The investigators focused on AVB patients undergoing permanent pacemaker implantations from the 1st of January 2018 to the 18th of November 2021 at West China Hospital.

Description:

Right ventricular pacing (RVP) is the standard treatment for patients with continuous ventricular pacing needs. However, clinical studies have shown that RVP can cause electrical and mechanical dyssynchrony of the left ventricle and increase the risks of cardiac insufficiency, atrial fibrillation (AF) and death. Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. In this study, the investigators aim to conduct a comparison of the safety and effectiveness performance between these two pacing methods for patients with atrioventricular block (AVB). The investigators focused on AVB patients undergoing permanent pacemaker implantations from the 1st of January 2018 to the 18th of November 2021 at West China Hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• included consecutively high-grade AVB patients undergoing permanent pacemaker implantations from the 1 s t of January 2018 to the 18 thof November 2021 at West China Hospital

Exclusion Criteria:

• patients with pacemaker replacements were excluded.

Related Conditions & MeSH terms

• Atrioventricular Block
• AVB - Atrioventricular Block

Intervention

Procedure:
• left bundle branch pacing (LBBP)
After recording the His potential, the 3830-69 lead (Medtronic Inc., Minneapolis, MN USA) was sent 1-2 cm forward and downward to find the insertion point of the right side of intra-ventricular septum combined with the pre-rotation impedance and ECG changes. Ultimately, the tip was perpendicularly straightforward posited against the septum to the left septal side .
• Right ventricular pacing (RVP)
Right ventricular pacing (RVP) is the standard treatment for patients with continuous ventricular pacing needs.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Sichuan	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups	composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups	through study completion, an average of 2.45 year
Primary	Lead failure	reintervention for increased pacing thresholds, lead dislocation or ventricular perforation after the initial implantation procedure	through study completion, an average of 2.45 year
Primary	HFH	HFH was defined as the admission to hospital for >24 hours with worsening symptoms and signs of heart failure and requiring one or more intravenous diuretics or intravenous inotropic medications	through study completion, an average of 2.45 year
Secondary	peri-procedure complication	included pericardial tamponade and pneumothorax	through study completion, an average of 2.45 year
Secondary	cardiac death	documented arrhythmogenic death, an unexpected presumed pulseles condition with the absence of an obvious noncardiac explanation, or a death due to congestive cardiac failure or structural heart disease	through study completion, an average of 2.45 year
Secondary	recurrent unexplained syncope	recurrent unexplained syncope	through study completion, an average of 2.45 year