Immediate Electrophysiological Effects of Different Atrial Pacing Sites on P-Wave Characteristics (Multi-site AP)

May 18, 2026 updated by: Shanghai Tong Ren Hospital

Prospective Within-Subject Evaluation of Immediate Electrophysiological Effects of Multiple Atrial Pacing Sites on Atrial Activation and P-Wave Morphology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China
        • Not yet recruiting
        • Affiliated Hospital of Zunyi Medical College
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200336
        • Recruiting
        • Tong Ren Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm-sequential multi-site atrial pacing
Participants will undergo sequential short-term atrial pacing at multiple predefined anatomical sites during standard pacemaker implantation, including the right atrial appendage (RAA), atrial septum, Bachmann's bundle (BB) area, and posterosuperior bundle (PSB) regions (high and low levels). PSB pacing will be kept with the remaining implantation procedure.
Procedure: Multi-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atrial-paced ECG P-wave duration
Time Frame: During implantation
During implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Atrial-paced ECG P-wave morphology
Time Frame: During implantation
During implantation
Atrial-paced ECG P-wave polarity in inferior leads (II, III, aVF)
Time Frame: During implantation
During implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Tong Ren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Multi-site AP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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