Health TrialsbyHealthPanel

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

ConditionsPacing TherapyCardiac Pacing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Tong Ren Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Multi-site short-time pacing

    Procedure/Surgery

    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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: single arm-sequential multi-site atrial pacingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Atrial-paced ECG P-wave duration

Time frame
During implantation

Secondary outcomes

1

Atrial-paced ECG P-wave morphology

Time frame
During implantation
2

Atrial-paced ECG P-wave polarity in inferior leads (II, III, aVF)

Time frame
During implantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Tong Ren Hospital

Lead sponsor

Source ClinicalTrials.gov
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