NCT07603648

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Oct 2026

Study Start

First participant enrolled

March 31, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Pacing TherapyCardiac Pacing

Keywords

atrial pacingphysiological pacingBachmann's bundle pacingPosterosuperior bundle pacing

Outcome Measures

Primary Outcomes (1)

  • Atrial-paced ECG P-wave duration

    During implantation

Secondary Outcomes (2)

  • Atrial-paced ECG P-wave morphology

    During implantation

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

    During implantation

Study Arms (1)

single arm-sequential multi-site atrial pacing

EXPERIMENTAL

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

Interventions

Multi-site short-time pacingPROCEDURE

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.

single arm-sequential multi-site atrial pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Affiliated Hospital of Zunyi Medical College

Zunyi, Guizhou, China

NOT YET RECRUITING

Tong Ren Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200336, China

RECRUITING

Central Study Contacts

Zhaohui Qiu

CONTACT

+862152039999qzh3503@shtrhospital.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)