Pacing TherapyBBAP-ECG/echoNCT06995027
ECG and Echo Characteristics of BBAP
A study testing BBAP and RAA pacing in people with Pacing Therapy and Cardiac Pacing, run by Shanghai Tong Ren Hospital at 1 site in China.
Trial summary
This is a prospective, single-site, non-randomized, interventional study. The purpose is to collect electrocardiographic (ECG) and echocardiographic (echo) parameters and computed tomography (CT) images (optional) during Bachmann's bundle area pacing (BBAP) and conventional pacing in the right atrial appendage (RAA)… 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?
- BBAP and RAA pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients aged >= 18 years old
- Patients who are willing to provide Informed Consent
- Patients who are indicated to atrial pacing, dual-chamber pacing, or cardiac resynchronization therapy
- Patients who consent to Bachmann's bundle area pacing
Who cannot join
- Patients who are indicated for cardiac implantable electronic device replacement or upgrade
- Patients with defibrillation indications
- Patients who are pregnant or have a plan for pregnancy during the study
- Patients who have medical conditions that would limit study participation
- Patients who were already enrolled in other trials which would impact his/her participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrocardiographic and Echocardiographic Characteristics of Bachmann's Bundle Area Pacing
This is a prospective, single-site, non-randomized, interventional study. The purpose is to collect electrocardiographic (ECG) and echocardiographic (echo) parameters and computed tomography (CT) images (optional) during Bachmann's bundle area pacing (BBAP) and conventional pacing in the right atrial appendage (RAA) to compare the differences between atrial pacing modalities and to further investigate the clinical outcomes of BBAP.
Read the detailed description
Bachmann's bundle (BB) has emerged as an alternative pacing location to conventional right atrial appendage (RAA) pacing and is expected to avoid the interatrial conduction delay (IACD) and atrial dyssynchrony induced by RAA pacing. A recent study reported in patients with atrial pacing indications and baseline IACD that decreased atrial arrhythmia burden, recurrence, and de novo incidence were found in BB pacing, compared with right atrial septal pacing and RAA pacing. This study aimed to collect electrocardiographic (ECG) and echocardiographic (echo) parameters and CT images during BB area pacing (BBAP) and conventional pacing in the right atrial appendage (RAA) during regular pacemaker implantation procedures. The purpose is to compare the differences between atrial pacing modalities and to further investigate the clinical outcomes of BBAP.
- Conditions
- Pacing Therapy, Cardiac Pacing
- Being tested
- BBAP and RAA pacing
- Keywords
- Bachmann's bundle pacing, Bradycardia, Physiological pacing
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBAP and RAA pacingProcedure or surgery
Bachmann's bundle area pacing and conventional pacing in the right atrial appendage during regular pacemaker implantation procedures are applied for acute electrocardiogram and echocardiogram testings.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - BBAP and RAA pacing | Experimental | Bachmann's bundle area pacing (BBAP) and conventional pacing in the right atrial appendage during regular pacemaker implantation procedures are applied for acute electrocardiogram and echocardiogram testings. BBAP will be kept with remaining implantation procedure and followed-up at 3 months and/or 6 months. Receives: Procedure: BBAP and RAA pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial-paced ECG P-wave duration at implantation and during regular follow-ups
Measured: From implantation to regular follow-ups up to 6 months
Atrial-paced ECG P-wave amplitude at implantation and during regular follow-ups
Measured: From implantation to regular follow-ups up to 6 months
Atrial-paced P-onset to A-wave initiation time under Doppler at mitral and tricuspid valves at implantation
Measured: Perioperative
Secondary outcomes (1)
LAD from echocardiographic measurements before implantation and during regular follow-ups
Measured: Baseline before implantation to regular follow-ups up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start31 Aug 2024
- Primary completion30 May 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 31 participants (actual)
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
- NCT06995027
- Sponsor's protocol ID
- BBAP-ECG/echo
- Acronym
- BBAP-ECG/echo
- Status last verified
- May 2026
- First submitted
- 23 Apr 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qiu Z, Wu X, Hu W, Tang Y, Xu Z, Ou Z, Zhou Y, Ren Z, Shi T, Lu H. Interatrial Synchronized Pacing at the Posterosuperior Bundle: Feasibility, Mechanism, and Mid-Term Outcomes. Circ Arrhythm Electrophysiol. 2026 Jan;19(1):e014357. doi: 10.1161/CIRCEP.125.014357. Epub 2025 Dec 25.
PubMed 41446938
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiographic and Echocardiographic Characteristics of Bachmann's Bundle Area Pacing
- ClinicalTrials.gov ID
- NCT06995027
- Acronym / sponsor ID
- BBAP-ECG/echo / BBAP-ECG/echo
- Conditions
- Pacing Therapy, Cardiac Pacing
- Keywords
- Bachmann's bundle pacing, Bradycardia, Physiological pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Shanghai Tong Ren HospitalUniversity, hospital or other
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 May 2025 (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-site, non-randomized, interventional study. The purpose is to collect electrocardiographic (ECG) and echocardiographic (echo) parameters and computed tomography (CT) images (optional) during Bachmann's bundle area pacing (BBAP) and conventional pacing in the right atrial appendage (RAA) to compare the differences between atrial pacing modalities and to further investigate the clinical outcomes of BBAP.
Detailed description
Bachmann's bundle (BB) has emerged as an alternative pacing location to conventional right atrial appendage (RAA) pacing and is expected to avoid the interatrial conduction delay (IACD) and atrial dyssynchrony induced by RAA pacing. A recent study reported in patients with atrial pacing indications and baseline IACD that decreased atrial arrhythmia burden, recurrence, and de novo incidence were found in BB pacing, compared with right atrial septal pacing and RAA pacing. This study aimed to collect electrocardiographic (ECG) and echocardiographic (echo) parameters and CT images during BB area pacing (BBAP) and conventional pacing in the right atrial appendage (RAA) during regular pacemaker implantation procedures. The purpose is to compare the differences between atrial pacing modalities and to further investigate the clinical outcomes of BBAP.
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 - BBAP and RAA pacing | Experimental | Procedure: BBAP and RAA pacingBachmann's bundle area pacing (BBAP) and conventional pacing in the right atrial appendage during regular pacemaker implantation procedures are applied for acute electrocardiogram and echocardiogram testings. BBAP will be kept with remaining implantation procedure and followed-up at 3 months and/or 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged >= 18 years old
- Patients who are willing to provide Informed Consent
- Patients who are indicated to atrial pacing, dual-chamber pacing, or cardiac resynchronization therapy
- Patients who consent to Bachmann's bundle area pacing
Key exclusion criteria (5 listed)
- Patients who are indicated for cardiac implantable electronic device replacement or upgrade
- Patients with defibrillation indications
- Patients who are pregnant or have a plan for pregnancy during the study
- Patients who have medical conditions that would limit study participation
- Patients who were already enrolled in other trials which would impact his/her participation
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 |
|---|---|---|
| BBAP and RAA pacingBachmann's bundle area pacing and conventional pacing in the right atrial appendage during regular pacemaker implantation procedures are applied for acute electrocardiogram and echocardiogram testings. | Procedure or surgery | Single Arm - BBAP and RAA pacing |
Primary outcome
Atrial-paced ECG P-wave duration at implantation and during regular follow-ups
Time frame: From implantation to regular follow-ups up to 6 months
Atrial-paced ECG P-wave amplitude at implantation and during regular follow-ups
Time frame: From implantation to regular follow-ups up to 6 months
Atrial-paced P-onset to A-wave initiation time under Doppler at mitral and tricuspid valves at implantation
Time frame: Perioperative
1 secondary outcome
LAD from echocardiographic measurements before implantation and during regular follow-ups
Time frame: Baseline before implantation to regular follow-ups up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 41446938Qiu Z, Wu X, Hu W, Tang Y, Xu Z, Ou Z, Zhou Y, Ren Z, Shi T, Lu H. Interatrial Synchronized Pacing at the Posterosuperior Bundle: Feasibility, Mechanism, and Mid-Term Outcomes. Circ Arrhythm Electrophysiol. 2026 Jan;19(1):e014357. doi: 10.1161/CIRCEP.125.014357. Epub 2025 Dec 25.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BBAP and RAA pacing in people with Pacing Therapy and Cardiac Pacing, run by Shanghai Tong Ren Hospital at 1 site 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 5 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: finished, as of the sponsor's last update on 20 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial-paced ECG P-wave duration at implantation and during regular follow-ups (time frame: From implantation to regular follow-ups up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06995027, which also lists 1 linked publication.
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 20 May 2026.