Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure

Heart Failure Clinical Trial

— LBBAP-AFHF  

Official title:

Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure ：A Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05549544
• Other study ID #: 2022-1704
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Fu Wai Hospital, Beijing, China
• Contact: Haojie Zhu, M.D
• Phone: +8613167310573
• Email: 13167310573[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients aged more than 18 years old

• Patients diagnosed with heart failure (LVEF<50%) and have received optimal medical therapy for at least 3 months

• Patients with permanent atrial fibrillation (QRS duration <130ms) which need ventricular pacing, including:

1. LVEF<50%, NYHA II-IV, drug-refractory atrial fibrillation with the fast ventricular rate, planned atrioventricular nodal ablation due to 1). anticipated low success rate of atrial fibrillation catheter ablation or 2). patients refused to receive catheter ablation or 3). refused to receive another catheter ablation after a previous history of failed procedures

2. LVEF<50%, NYHA II-IV, atrial fibrillation with slow ventricular rate, anticipated ventricular pacing burden = 40%

• Written informed consent was provided

Exclusion Criteria:

• expected survival time is less than 12 months

• Prior history of mechanical tricuspid valve replacement and/or congenital heart disease (including dextrocardia, transposition of the great arteries, single left persistent left superior vena cava, etc.)

• Plan for PCI or CABG due to unstable angina or myocardial infarction in 3 months

• Surgery is required within 1 year due to severe structural heart disease

• Pregnancy, planned pregnancy or heart transplant

• Prior history of HCM and/or ventricular septal defect repair, who are unlikely to achieve successful LBBAP procedure.

• Failure of lead placement due to abnormal anatomy of the coronary sinus or enlarged right atrium, which makes it unable to switch from one pacing modality to another

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Left Bundle Branch Area Pacing
• Permanent Atrial Fibrillation

Intervention

Device:
• Left bundle branch area pacing
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
Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The first affiliated hospital of Nanjing medical university	Nanjing	Jiangsu
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (5)

Lead Sponsor	Collaborator
Fu Wai Hospital, Beijing, China	Peking University First Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital with Nanjing Medical University, The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?LVEF between baseline and six months post-discharge	?LVEF:change in LVEF between baseline and six months after procedure	Six months after device implantation
Secondary	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).	1 weeks
Secondary	The rate of procedure and Device related complications	Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications	6 months
Secondary	?LVEDD between baseline and six months post-discharge	?LVEDD:change in LVEDD between baseline and six months after procedure between two groups	6 months
Secondary	?LVEDV between baseline and six months post-discharge	?LVEDV:change in LVEDV between baseline and six months after procedure between two groups	6 months
Secondary	The echocardiographic response rate of LVEF increase =5%	the percentage of patients with change of LVEF =5% at 6 month from baseline	6 months
Secondary	The changes of NT-proBNP betwen baseline and 6 months post-discharge	The changes of NT-proBNP betwen baseline and 6 months post-discharge	6 months
Secondary	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.	6 months
Secondary	The echocardiographic response rate of LVEF increase =15%	an increase in LVESV =15% during follow-up at 6 month compared with baseline	6 months
Secondary	The rate of ?LVESV =15% between baseline and six months post-discharge	the percentage of patients with change of ?LVESV =15% at 6 month from baseline	6 months