Biventricular Pacing, Heart Failure, Left Bundle Branch Area Pacing, Permanent Atrial Fibrillation
Conditions
Keywords
Left Bundle Branch Area Pacing, Permanent Atrial Fibrillation, Heart Failure, Biventricular Pacing
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.
Interventions
DEVICELeft 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.
DEVICEBiventricular pacing
Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure
Sponsors
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
Fu Wai Hospital, Beijing, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ΔLVEF between baseline and six months post-discharge | Six months after device implantation | ΔLVEF：change in LVEF between baseline and six months after procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of procedure and Device related complications | 6 months | Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications |
| ΔLVEDD between baseline and six months post-discharge | 6 months | ΔLVEDD：change in LVEDD between baseline and six months after procedure between two groups |
| ΔLVEDV between baseline and six months post-discharge | 6 months | ΔLVEDV：change in LVEDV between baseline and six months after procedure between two groups |
| The echocardiographic response rate of LVEF increase ≥5% | 6 months | the percentage of patients with change of LVEF ≥5% at 6 month from baseline |
| The immediate success rate of the LBBAP procedure | 1 weeks | 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). |
| Composite incidence rate of all-cause mortality and/or hospitalization for heart failure | 6 months | 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. |
| The echocardiographic response rate of LVEF increase ≥15% | 6 months | an increase in LVESV ≥15% during follow-up at 6 month compared with baseline |
| The rate of ΔLVESV ≥15% between baseline and six months post-discharge | 6 months | the percentage of patients with change of ΔLVESV ≥15% at 6 month from baseline |
| The changes of NT-proBNP betwen baseline and 6 months post-discharge | 6 months | The changes of NT-proBNP betwen baseline and 6 months post-discharge |
Countries
China
Contacts
Primary ContactHaojie Zhu, M.D
Backup ContactXiaofei Li, M.D
Outcome results
None listed