Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block
- Conditions
- AVB - Atrioventricular Block
- Interventions
- Procedure: left bundle branch pacing (LBBP)Procedure: Right ventricular pacing (RVP)
- Registration Number
- NCT05722379
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- patients with pacemaker replacements were excluded.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description high-grade AVB patients undergoing permanent pacemaker implantations Right ventricular pacing (RVP) - high-grade AVB patients undergoing permanent pacemaker implantations left bundle branch pacing (LBBP) -
- Primary Outcome Measures
Name Time Method 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 composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups
Lead failure through study completion, an average of 2.45 year reintervention for increased pacing thresholds, lead dislocation or ventricular perforation after the initial implantation procedure
HFH through study completion, an average of 2.45 year 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
- Secondary Outcome Measures
Name Time Method peri-procedure complication through study completion, an average of 2.45 year included pericardial tamponade and pneumothorax
cardiac death through study completion, an average of 2.45 year 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
recurrent unexplained syncope through study completion, an average of 2.45 year recurrent unexplained syncope
Trial Locations
- Locations (1)
West China Hospital, Sichuan University
🇨🇳Sichuan, Sichuan, China