Immediate Electrophysiological Effects of Different Atrial Pacing Sites on P-Wave Characteristics (Multi-site AP)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Zhaohui Qiu
- Telefonnummer: +862152039999
- E-post: qzh3503@shtrhospital.com
Studiesteder
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Guizhou
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Zunyi, Guizhou, Kina
- Har ikke rekruttert ennå
- Affiliated Hospital of Zunyi Medical College
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Ta kontakt med:
- Xianping Long
- Telefonnummer: +86 13885294999
- E-post: longxianping1201@163.com
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200336
- Rekruttering
- Tong Ren Hospital, Shanghai Jiaotong University School of Medicine
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Ta kontakt med:
- Zhaohui Qiu
- Telefonnummer: +862152039999
- E-post: qzh3503@shtrhospital.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Atrial-paced ECG P-wave duration
Tidsramme: During implantation
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During implantation
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Atrial-paced ECG P-wave morphology
Tidsramme: During implantation
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During implantation
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Atrial-paced ECG P-wave polarity in inferior leads (II, III, aVF)
Tidsramme: During implantation
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During implantation
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Multi-site AP
Plan for individuelle deltakerdata (IPD)
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