Clinical trial NCT05722379: Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block
Official title: Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block: an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AVB - Atrioventricular Block
Keywords: Left bundle branch pacing
Right ventricular pacing
Mortality
Systolic dyssynchrony
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups
timeFrame: through study completion, an average of 2.45 year
measure: Lead failure
timeFrame: through study completion, an average of 2.45 year
measure: HFH
timeFrame: through study completion, an average of 2.45 year
Secondary outcomes:
measure: peri-procedure complication
timeFrame: through study completion, an average of 2.45 year
measure: cardiac death
timeFrame: through study completion, an average of 2.45 year
measure: recurrent unexplained syncope
timeFrame: through study completion, an average of 2.45 year
Other outcomes:
Locations:
city: Sichuan
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References: