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NCT07531368

BBAP With CS Mapping Guidance

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05-01

Completion Date

2027-12-31

Last Updated

2026-04-15

Healthy Volunteers

Conditions

Heart Failure

Interventions

DEVICE

CS mapping guidance

Selection of the optimal target site for atrial lead: In the 10-pole guided group, the electrode pair position with the lowest threshold + shortest LAAT time is selected as the lead implantation target;

DEVICE

ECG guidance

in the control group, the implantation site meeting the Lustgarten standard is selected

Inclusion Criteria: * \- 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 Exclusion Criteria: * 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

Clinical Research Directory

BBAP With CS Mapping Guidance

Summary

Key Details

Conditions

Interventions

Eligibility Criteria