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

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

Sponsors

Lead Sponsor: Fu Wai Hospital, Beijing, China

Collaborator: The Second Hospital of Hebei Medical University
The First Affiliated Hospital with Nanjing Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Peking University First Hospital

Source Fu Wai Hospital, Beijing, China
Brief 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

Detailed 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.

Overall Status Recruiting
Start Date 2022-07-18
Completion Date 2024-11-01
Primary Completion Date 2023-11-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
ΔLVEF between baseline and six months post-discharge Six months after device implantation
Secondary Outcome
Measure Time Frame
The immediate success rate of the LBBAP procedure 1 weeks
The rate of procedure and Device related complications 6 months
ΔLVEDD between baseline and six months post-discharge 6 months
ΔLVEDV between baseline and six months post-discharge 6 months
The echocardiographic response rate of LVEF increase ≥5% 6 months
The changes of NT-proBNP betwen baseline and 6 months post-discharge 6 months
Composite incidence rate of all-cause mortality and/or hospitalization for heart failure 6 months
The echocardiographic response rate of LVEF increase ≥15% 6 months
The rate of ΔLVESV ≥15% between baseline and six months post-discharge 6 months
Enrollment 60
Condition
Intervention

Intervention Type: Device

Intervention Name: Left bundle branch area pacing

Description: 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.

Arm Group Label: LBBAP group

Intervention Type: Device

Intervention Name: Biventricular pacing

Description: Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure

Arm Group Label: BiVP group

Eligibility

Criteria:

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 (mean heart rate ≥ 100 bpm after beta-blockers and/or digoxin for at least 1 month), 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). receive another catheter ablation after the 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Xiaohan Fan, PhD Principal Investigator Chinese Academy of Medical Sciences, Fuwai Hospital
Overall Contact

Last Name: Haojie Zhu, M.D

Phone: +8613167310573

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences | Beijing, Beijing, 100037, China Recruiting Haojie Zhu +8613167310573 [email protected] Xiaohan Fan Principal Investigator
Peking University First Hospital | Beijing, Beijing, 100037, China Not yet recruiting Jing Zhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou, Guangdong, China Not yet recruiting Yangxin Chen
The Second Hospital of Hebei Medical University | Shijiazhuang, Hebei, China Not yet recruiting Ruiqin Xie [email protected]
The first affiliated hospital of Nanjing medical university | Nanjing, Jiangsu, China Not yet recruiting Jiangang Zou
Location Countries

China

Verification Date

2022-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital

Investigator Full Name: Xiaohan Fan

Investigator Title: Professor, MD, PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: LBBAP group

Type: Experimental

Description: Device: Left bundle branch area pacing(LBBAP) LBBAP is a novel physiological pacing form for ventricular pacing. In patients who received LBBAP, the pacing lead will be placed at the left bundle branch area to achieve a narrow-paced QRS duration.

Label: BiVP group

Type: Active Comparator

Description: Device: Biventricular pacing (BiVP) Biventricular pacing is the traditional pacing modality for patients with heart failure. For BiVP, one pacing lead was placed in the coronary sinus, named LV lead, and another lead was placed in the right ventricule.

Acronym LBBAP-AFHF
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

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