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