Cardiac Pacing, Pacing Therapy
Conditions
Keywords
atrial pacing, physiological pacing, Bachmann's bundle pacing, Posterosuperior bundle pacing
Brief summary
This is a prospective, single-center, non-randomized, within-subject interventional study. The purpose is to compare the immediate effects of different atrial pacing sites on atrial electrical activation, as reflected by P-wave characteristics on surface electrocardiography (ECG). During pacemaker implantation, short-term pacing will be performed sequentially at multiple predefined atrial sites, including the right atrial appendage (RAA), atrial septum, Bachmann's bundle (BB) area, and posterosuperior bundle (PSB) regions. ECG parameters will be recorded at each site to evaluate differences in P-wave duration and morphology.
Detailed description
Atrial pacing site plays a key role in determining atrial activation sequence and interatrial synchrony. Conventional right atrial appendage (RAA) pacing has been associated with delayed and non-physiological atrial activation, whereas alternative sites such as the atrial septum and Bachmann's bundle (BB) may better preserve physiological conduction.Posterosuperior bundle (PSB) pacing has recently been proposed as a novel physiological atrial pacing strategy. This study is designed to evaluate the acute electrophysiological effects of different atrial pacing sites within the same individual. During routine pacemaker implantation, sequential short-term pacing will be performed at predefined atrial sites (RAA, atrial septum, BB area, high PSB, and low PSB), with simultaneous 12-lead ECG recording. The primary objective is to compare P-wave duration across pacing sites. Secondary analyses include P-wave morphology and polarity. The study aims to identify the atrial pacing site that most closely approximates physiological atrial activation and to provide mechanistic insights to guide optimal site selection.
Interventions
PROCEDUREMulti-site short-time pacing
Short-time atrial pacing at right atrial appendage (RAA), atrial septum, Bachmann's bundle (BB) area, and posterosuperior bundle (PSB) regions (high and low levels) during regular pacemaker implantation procedures are applied for acute electrocardiogram and echocardiogram testings.
Sponsors
Shanghai Tong Ren Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Sinus rhythm at baseline * Indication for permanent pacemaker implantation with planned atrial lead placement * Willing and able to provide written informed consent
Exclusion criteria
* Long-standing persistent or permanent atrial fibrillation, or prior atrioventricular node ablation * Prior cardiac implantable electronic device (CIED) requiring revision, replacement, or upgrade * Indication for implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) * Significant valvular heart disease, cardiomyopathy, or prior cardiac surgery * Angina or acute myocardial infarction within 3 months before enrollment * Chronic use of antiarrhythmic drugs * Severe hepatic or renal dysfunction, or other serious systemic diseases * Participation in another clinical study that may interfere with the objectives of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial-paced ECG P-wave duration | During implantation |
Secondary
| Measure | Time frame |
|---|---|
| Atrial-paced ECG P-wave morphology | During implantation |
| Atrial-paced ECG P-wave polarity in inferior leads (II, III, aVF) | During implantation |
Countries
China
Contacts
CONTACTZhaohui Qiu
Outcome results
None listed