Efficacy and Safety of Atrial Lead Placement Targeting Bachmann's Bundle Under Guidance of Left Atrial Potential Mapping Via the Coronary Sinus for Cardiac Resynchronization Therapy Pacing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Technical success rate
研究概览
简要总结
Study Title
Efficacy and Safety of Coronary Sinus-Based Left Atrial Mapping for Guiding Atrial Lead Implantation Targeting Bachmann Bundle Capture in Cardiac Resynchronization Therapy Research Objectives
This study intends to use a 10-pole coronary sinus (CS) catheter to map left atrial activation time, assist in identifying the Bachmann bundle (BB) region, and further guide Bachmann bundle atrial pacing (BBAP) lead implantation. The anatomical relationship between the lead and the Bachmann bundle will be displayed by postoperative computed tomographic angiography (CTA), thereby verifying the efficacy and safety of this method in guiding BBAP surgical operations.
Study Endpoints
Primary Endpoint
- Technical success rate Key Secondary Endpoints
- Procedure time② Radiation dose③ Number of attempts for atrial lead screw-in during the operation: cumulative number of atrial lead implantation attempts during the operation④ Lead repositioning/reoperation rate⑤ Changes in electrical parameters (pacing threshold, lead impedance, intracardiac sensing) of the atrial lead at immediate postoperative, 1-month, 3-month, 6-month, 9-month, and 12-month follow-up⑥ Comparison of the effects of BBAP and right atrial appendage pacing (RAAP) on acute intraoperative hemodynamics⑦ Comparison of the differences in atrial high-rate (AHR) response in pacemaker programming data between BBAP and RAAP during 1-month, 3-month, 6-month, 9-month, and 12-month follow-up Safety Endpoints
- Major safety endpoint: Composite of severe complications② Minor safety endpoint: Incidence of specific adverse events Exploratory Endpoints
Health economics, electrophysiological indicators Secondary Efficacy Endpoints
To be further clarified according to the study design and clinical data collection.
Revisions Summary
Full expansion of all abbreviations on first occurrence CS = coronary sinus BB = Bachmann bundle BBAP = Bachmann bundle atrial pacing CTA = computed tomographic angiography RAAP = right atrial appendage pacing AHR = atrial high-rate Minor wording & clarity improvements Specified "pacing threshold, lead impedance, intracardiac sensing" for clearer electrical parameter description Spelling/typo check No spelling errors, typos, or grammatical issues identified in the original text Consistent terminology maintained throughout
详细描述
This is a single-blind, randomized, controlled, multi-center clinical trial designed to evaluate the efficacy and safety of coronary sinus (CS)-based left atrial mapping for guiding atrial lead implantation targeting Bachmann bundle (BB) capture in patients undergoing cardiac resynchronization therapy (CRT). The core objective is to validate whether using a 10-pole CS catheter to map left atrial activation time (LAAT) can improve the accuracy of BB region identification and subsequent Bachmann bundle atrial pacing (BBAP) lead implantation, compared with the conventional Lustgarten standard approach.
Study Design and Randomization
The study adopts a fixed block randomization method, with random numbers generated by independent statisticians using a computerized random number generation program to ensure allocation concealment. Single-blinding is implemented, where patients are unaware of the atrial lead implantation method they receive; investigators responsible for intraoperative operations and postoperative follow-up assessments (excluding those involved in randomization) are also kept blinded to the grouping to minimize detection bias. The study includes two parallel groups: the CS 10-pole mapping LAAT guided group and the Lustgarten standard control group, with 20 subjects in each group, totaling 40 subjects across multiple participating centers.
Preoperative Preparation and Screening
Potential subjects undergo a comprehensive screening period of 28 to 1 day before enrollment (Day -28 to Day -1). After signing the informed consent form (ICF), subjects complete detailed medical history collection, physical examination, and a series of laboratory and auxiliary examinations to confirm eligibility. Key preoperative assessments include 12-lead electrocardiogram (ECG) (with left bundle branch block (LBBB) morphology confirmed by the core ECG laboratory), transthoracic echocardiography (TTE) to measure left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), and left atrial volume index (LAVI) via Simpson's biplane method, 24-hour ambulatory ECG (Holter) to assess arrhythmia burden and expected ventricular pacing proportion, and chest X-ray to evaluate heart size and planned lead pathways. All subjects must have completed at least 3 months of guideline-directed medical therapy (GDMT) optimization before enrollment, with eligibility confirmed by the principal investigator (PI) prior to randomization.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 1 Sinus rhythm
- •2 Left ventricular ejection fraction (LVEF) ≤ 35%, QRS duration ≥ 150 ms; or 130 ms < QRS duration < 150 ms with left bundle branch block (LBBB) morphology
- •3 LVEF ≤ 40% with expected ventricular pacing > 20%
- •4 New York Heart Association (NYHA) class II, III, or ambulatory IV symptoms
- •5 After at least 3 months of guideline-directed medical therapy (GDMT) optimization
- •6 Age ≥ 18 years
- •7 Signed informed consent form, good compliance, and ability to complete study follow-up
排除标准
- •Prior implantation of CRT/ICD/pacemaker: Previous implantation of any cardiac implantable electronic device (CIED), except for patients in Group C requiring device replacement/upgrade
- •Non-compliance with GDMT requirements: Failure to receive or inability to tolerate optimized medical therapy
- •Inappropriate QRS duration: QRS < 130 ms (Groups A and C)
- •Excessive improvement in LVEF: Recent (within 3 months) LVEF > 40% with clear evidence of normalized cardiac function
- •Severe valvular heart disease: Severe aortic stenosis/regurgitation, mitral stenosis requiring surgical or interventional treatment
- •Recent cardiovascular events: Acute myocardial infarction, stroke/transient ischemic attack (TIA) within 3 months before enrollment; coronary revascularization (PCI or CABG) within 6 months before enrollment
- •Unstable angina pectoris: Canadian Cardiovascular Society (CCS) class III-IV
- •Severe arrhythmias: History of sustained ventricular tachycardia or ventricular fibrillation (without ICD protection)
- •Types of cardiomyopathy: Hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy (ARVC), and other specific etiologies not suitable for CRT
- •Severe renal insufficiency: Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m² or uncontrolled renal failure
- •Severe liver dysfunction: Child-Pugh class C
- •Active infection: Including sepsis, infective endocarditis, etc.
- •Malignant tumor: Advanced malignant tumor with expected survival < 12 months
- •Pregnancy or lactation: Positive pregnancy test in women of childbearing age or planned pregnancy
- •Cognitive impairment: Inability to provide informed consent or follow the study protocol
- •Mental illness: Severe mental disorders affecting treatment compliance
- •Geographical restrictions: Inability to maintain contact or return to the medical center regularly during follow-up
- •Venous access disorders: Inability to implant CRT via venous route (e.g., bilateral subclavian vein occlusion)
- •Contralateral device: Implanted contralateral CIED leading to risk of lead crossing or interference
- •Participation in other interventional clinical trials, or other conditions deemed unsuitable for enrollment by the investigator
研究组 & 干预措施
CS mapping guidance
干预措施: CS mapping guidance (Device)
ECG guidance
干预措施: ECG guidance (Device)
结局指标
主要结局
Technical success rate
时间窗: Day 1 after the BBAP procedure (From the date of BBAP lead implantation until the date of postoperative computed tomographic angiography (CTA) confirmation before discharge, assessed on Day 1 postoperatively)
Endpoint name: Success rate of BBAP lead implantation Definition: The proportion of subjects in the study group (guided by 10-pole mapping LAAT) or control group (Lustgarten standard group) whose electrode lead tip reaches the Bachmann bundle region confirmed by postoperative computed tomographic angiography (CTA). Time Frame: From the date of BBAP lead implantation until the date of postoperative computed tomographic angiography (CTA) confirmation before discharge, assessed on Day 5-7 postoperatively Unit of Measure: Percentage (%) Calculation Method: Success rate of BBAP lead implantation = (Number of subjects in the group with lead tip confirmed by CTA to reach the Bachmann bundle region / Number of subjects randomized to the corresponding group) × 100%
次要结局
- Secondary Outcome Measure(the day of the procedure)
研究者
Yixiu Liang
doctor
Shanghai Zhongshan Hospital