Pacing TherapyMulti-site APNCT07603648
Immediate Electrophysiological Effects of Different Atrial Pacing Sites on P-Wave Characteristics
A study testing Multi-site short-time pacing in people with Pacing Therapy and Cardiac Pacing, run by Shanghai Tong Ren Hospital at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacing Therapy, Cardiac Pacing
- What is being tested?
- Multi-site short-time pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesChina
- Study dates
- 31 Mar 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Tong Ren Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200336
Zhaohui Qiu, +862152039999, qzh3503@shtrhospital.com
- Not yet recruiting
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou
Xianping Long, +86 13885294999, longxianping1201@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pacing Therapy, Cardiac Pacing
- Being tested
- Multi-site short-time pacing
- Keywords
- atrial pacing, physiological pacing, Bachmann's bundle pacing, Posterosuperior bundle pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-site short-time pacingProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Multi-site short-time pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial-paced ECG P-wave duration
Measured: During implantation
Secondary outcomes (2)
Atrial-paced ECG P-wave morphology
Measured: During implantation
Atrial-paced ECG P-wave polarity in inferior leads (II, III, aVF)
Measured: During implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start31 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacing TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tong Ren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603648
- Sponsor's protocol ID
- Multi-site AP
- Acronym
- Multi-site AP
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Within-Subject Evaluation of Immediate Electrophysiological Effects of Multiple Atrial Pacing Sites on Atrial Activation and P-Wave Morphology
- ClinicalTrials.gov ID
- NCT07603648
- Acronym / sponsor ID
- Multi-site AP / Multi-site AP
- Conditions
- Pacing Therapy, Cardiac Pacing
- Keywords
- atrial pacing, physiological pacing, Bachmann's bundle pacing, Posterosuperior bundle pacing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shanghai Tong Ren HospitalUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm-sequential multi-site atrial pacing | Experimental | Procedure: Multi-site short-time pacingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-site short-time pacingShort-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. | Procedure or surgery | single arm-sequential multi-site atrial pacing |
Primary outcome
Atrial-paced ECG P-wave duration
Time frame: During implantation
2 secondary outcomes
Atrial-paced ECG P-wave morphology
Time frame: During implantation
Atrial-paced ECG P-wave polarity in inferior leads (II, III, aVF)
Time frame: During implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-site short-time pacing in people with Pacing Therapy and Cardiac Pacing, run by Shanghai Tong Ren Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Qiu (+862152039999, qzh3503@shtrhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial-paced ECG P-wave duration (time frame: During implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.