Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07603648

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

Led by Shanghai Tong Ren Hospital · Updated on 2026-05-22

35

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the immediate effects of pacing at different sites in the atrium during pacemaker implantation to understand how these sites influence atrial electrical activation. This study focuses on comparing P-wave characteristics on surface electrocardiography (ECG) to identify which atrial pacing site best preserves physiological conduction. The research is designed as a prospective, single-center, non-randomized interventional study involving patients indicated for permanent pacemaker implantation. During the procedure, 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 at both high and low levels. The pacing at these sites will be conducted during routine pacemaker implantation, with PSB pacing maintained for the remainder of the procedure. ECG parameters such as P-wave duration, morphology, and polarity will be recorded at each pacing site to assess differences. Participants will undergo sequential atrial pacing at the specified sites during implantation, with simultaneous 12-lead ECG recordings to evaluate electrical activation patterns. Researchers will measure P-wave duration as the primary outcome and analyze P-wave morphology and polarity as secondary outcomes during the implantation. This approach aims to provide insights that could guide optimal atrial lead placement. The study is expected to conclude in October 2026, and participation involves the duration of the implantation procedure only.

CONDITIONS

Brief Title

Immediate Electrophysiological Effects of Different Atrial Pacing Sites on P-Wave Characteristics

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Sinus rhythm at baseline
  • Indication for permanent pacemaker implantation with planned atrial lead placement
  • Willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Long-standing persistent or permanent atrial fibrillation, or prior atrioventricular node ablation
  • Prior cardiac implantable electronic device requiring revision, replacement, or upgrade
  • Indication for implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - During pacemaker implantation procedure

Participants undergo sequential short-term atrial pacing at multiple predefined anatomical sites during standard pacemaker implantation, including right atrial appendage, atrial septum, Bachmann's bundle area, and posterosuperior bundle regions.

1 procedure visit (in-person)

Trial Site Locations

Total: 2 locations

1

Affiliated Hospital of Zunyi Medical College

Zunyi, Guizhou, China

Not Yet Recruiting

2

Tong Ren Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200336

Actively Recruiting

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Research Team

Z

Zhaohui Qiu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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