This is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure
LBBAP-AFHF is a prospective, multicenter, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may show superiority of improved LV function as compared with traditional biventricular pacing (BiVP) in patients with permanent atrial fibrillation and heart failure (LVEF\<50%) who receive atrioventricular nodal ablation due to fast ventricular rate or require high percentage of ventricular pacing due to slow ventricular rate. The primary endpoint of this trial is the change in the LVEF at 6 months after device implantation from baseline. A CRT-P/D device would be implanted and LBBAP lead would be connected to the RA port and LV lead to the LV port. Patients who receive successful LBBAP and BiVP simultaneously during the procedure would be 1:1 randomized to LBBAP or BiVP group after the procedure by device programming. Patients will be followed at 3 and 6 months post-discharge for LVEF and other echographic parameters (including LVESV, response rate), and rehospitalization for heart failure or all-cause death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Left bundle branch area pacing is a novel physiological pacing modality and is reported to be feasible and safe in patients with heart failure and left bundle branch block.
Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
ΔLVEF between baseline and six months post-discharge
ΔLVEF:change in LVEF between baseline and six months after procedure
Time frame: Six months after device implantation
The immediate success rate of the LBBAP procedure
Successful LBBAP procedure is identified according to ECG and intracardiac ECG electrogram (IEGM) during the procedure. All LBBAP procedures will be categorized as selective left bundle branch pacing (S-LBBP), non-selective left bundle branch pacing(NS-LBBP), or left ventricular septal pacing (LVSP).
Time frame: 1 weeks
The rate of procedure and Device related complications
Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications
Time frame: 6 months
ΔLVEDD between baseline and six months post-discharge
ΔLVEDD:change in LVEDD between baseline and six months after procedure between two groups
Time frame: 6 months
ΔLVEDV between baseline and six months post-discharge
ΔLVEDV:change in LVEDV between baseline and six months after procedure between two groups
Time frame: 6 months
The echocardiographic response rate of LVEF increase ≥5%
the percentage of patients with change of LVEF ≥5% at 6 month from baseline
Time frame: 6 months
The changes of NT-proBNP betwen baseline and 6 months post-discharge
The changes of NT-proBNP betwen baseline and 6 months post-discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGThe first affiliated hospital of Nanjing medical university
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGTime frame: 6 months
Composite incidence rate of all-cause mortality and/or hospitalization for heart failure
All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.
Time frame: 6 months
The echocardiographic response rate of LVEF increase ≥15%
an increase in LVESV ≥15% during follow-up at 6 month compared with baseline
Time frame: 6 months
The rate of ΔLVESV ≥15% between baseline and six months post-discharge
the percentage of patients with change of ΔLVESV ≥15% at 6 month from baseline
Time frame: 6 months