Clinical trial NCT05549544: Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Left Bundle Branch Area Pacing
Biventricular Pacing
Heart Failure
Permanent Atrial Fibrillation
Keywords: Left Bundle Branch Area Pacing
Permanent Atrial Fibrillation
Heart Failure
Biventricular Pacing
Lead sponsor: Fu Wai Hospital, Beijing, China
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Hebei Medical University
name: The First Affiliated Hospital with Nanjing Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Peking University First Hospital
First posted: 2022-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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, 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

Primary outcomes:
measure: ΔLVEF between baseline and six months post-discharge
timeFrame: Six months after device implantation
Secondary outcomes:
measure: The immediate success rate of the LBBAP procedure
timeFrame: 1 weeks
measure: The rate of procedure and Device related complications
timeFrame: 6 months
measure: ΔLVEDD between baseline and six months post-discharge
timeFrame: 6 months
measure: ΔLVEDV between baseline and six months post-discharge
timeFrame: 6 months
measure: The echocardiographic response rate of LVEF increase ≥5%
timeFrame: 6 months
measure: The changes of NT-proBNP betwen baseline and 6 months post-discharge
timeFrame: 6 months
measure: Composite incidence rate of all-cause mortality and/or hospitalization for heart failure
timeFrame: 6 months
measure: The echocardiographic response rate of LVEF increase ≥15%
timeFrame: 6 months
measure: The rate of ΔLVESV ≥15% between baseline and six months post-discharge
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Nanjing
country: China
facility: The first affiliated hospital of Nanjing medical university
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiaohan Fan, PhD
role: PRINCIPAL_INVESTIGATOR
References: