Left Bundle Branch Area Pacing Versus Conventional Right Ventricular Pacing as Initial Strategy for Patients With Permanent Atrial Fibrillation and Preserved Left Ventricular Ejection Fraction Requiring Cardiac Pacing: an Open-label, Multicenter, Randomized Clinical Trial. - the BEAT Study -
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 642
- 主要终点
- Proportion of post-implantation adverse events
研究概览
简要总结
The goal of this clinical trial is to learn whether left bundle branch area pacing, a technique designed to activate the heart's natural electrical conduction system, is better than conventional right ventricular pacing in adults with permanent atrial fibrillation, preserved heart pumping function, and a need for a pacemaker.
The main questions it aims to answer are:
Does left bundle branch area pacing reduce the risk of death, unplanned hospitalization for heart failure, or the need to replace the initial pacing system with biventricular pacing over 2 years? Does it better preserve heart function and quality of life, without increasing pacemaker-related complications?
Researchers will compare left bundle branch area pacing with conventional right ventricular pacing. A total of 642 participants will be randomly assigned to receive one of these two pacing strategies.
Participants will:
Have a single-chamber pacemaker implanted using either left bundle branch area pacing or conventional right ventricular pacing Undergo electrocardiograms, echocardiograms, and pacemaker checks during 2 years of follow-up Attend follow-up visits approximately 2, 12, and 24 months after implantation Be contacted by telephone approximately 6 and 18 months after implantation Complete questionnaires about their health and quality of life at the beginning and end of the study
详细描述
The BEAT Study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to compare left bundle branch area pacing with conventional right ventricular pacing as the initial pacing strategy in adults with permanent atrial fibrillation, preserved left ventricular ejection fraction, and an indication for permanent ventricular pacing.
Conventional right ventricular pacing is the standard pacing strategy for patients with bradycardia. The ventricular lead is usually positioned at the right ventricular apex or septum. Although this approach is well established, prolonged right ventricular pacing produces a non-physiological pattern of ventricular electrical activation. The resulting electrical and mechanical dyssynchrony may progressively impair left ventricular function and lead to pacing-induced cardiomyopathy, heart failure, hospitalization, and the need for a subsequent procedure to upgrade the pacing system to biventricular pacing.
Patients with permanent atrial fibrillation who require a pacemaker may be particularly exposed to these complications because they generally have a high burden of ventricular pacing. This applies both to patients with slow atrial fibrillation and to those undergoing atrioventricular node ablation for rapid atrial fibrillation. Although these patients may have preserved left ventricular systolic function at the time of pacemaker implantation, repeated non-physiological ventricular activation could contribute to subsequent deterioration in cardiac function.
Left bundle branch area pacing is a conduction-system pacing technique in which the ventricular lead is advanced through the interventricular septum to stimulate the left bundle branch or the surrounding conduction tissue. By recruiting the heart's intrinsic conduction system, this approach is intended to produce more physiological and synchronous ventricular activation than conventional right ventricular pacing. It may therefore preserve left ventricular function and reduce the clinical consequences associated with long-term ventricular pacing.
Evidence supporting left bundle branch area pacing has increased, particularly in patients with impaired left ventricular function or an indication for cardiac resynchronization. However, long-term randomized evidence remains limited in patients with permanent atrial fibrillation, preserved left ventricular ejection fraction, and an expected high ventricular pacing burden. In particular, the effect of the initial pacing strategy on major clinical events in this population has not been adequately established.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and <90 years
- •Atrial fibrillation requiring ventricular pacing because of
- •rapid atrial fibrillation requiring atrioventricular node ablation; or
- •slow atrial fibrillation i.e. ≤ 50 bpm on admission ECG).
- •Left ventricular ejection fraction ≥50%.
- •Affiliated person or beneficiary of the French social security scheme
- •Having given their informed consent.
排除标准
- •Indication for an implantable cardioverter defibrillator.
- •Presence of a mechanical tricuspid valve
- •Any prior attempt at implantation of an implantable cardioverter defibrillator, cardiac resynchronization therapy or LBBA pacing
- •Glomerular filtration rate <40 mL/min/1,73m2 with CKD-EPI formula
- •Chronic respiratory failure
- •Serious medical condition with life expectancy of <2 years
- •Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)
- •Persons benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situations
研究组 & 干预措施
LBBA pacing
The LBBA pacing group will be composed of patients randomized to receive a single chamber pacemaker with a ventricular lead implanted in the LBBA of the cardiac conduction system through the interventricular septum.
干预措施: LBBA pacing (Procedure)
Conventional pacing
The conventional pacing group will be composed of patients randomized to receive a single chamber pacemaker with a ventricular lead implanted either at the apex or the septum of the right ventricle.
干预措施: Conventional pacing (Procedure)
结局指标
主要结局
Proportion of post-implantation adverse events
时间窗: At two years
proportion of post-implantation adverse events, combining all-cause mortality, unplanned hospitalization related to heart failure, and upgrade to biventricular pacing.
次要结局
- Left ventricular ejection fraction(At 2 years post-implantation.)
- Left ventricular end-systolic volume(At 2 years post-implantation)
- Time to composite outcome(Through study completion, an average of 2 years)
- Unplanned hospitalization related to heart failure(During the 2-year follow-up perio)
- All-cause mortality(During the 2-year follow-up period)
- Upgrade to biventricular pacing(During the 2-year follow-up period)
- Complications(During the 2-year follow-up period)
- Cardiac reintervention(During the 2-year follow-up period)
- Quality of life : Short Form 36 Questionnaire score(Evolution between baseline and 2 years post-implantation)
- Quality of life : Kansas City Cardiomyopathy Questionnaire score(Evolution between baseline and 2 years post-implantation)