Persistent Atrial FibrillationNCT07445360
Circumferential Pulmonary Venous Isolation Combined With Bachmann Bundle Modification Versus Circumferential Pulmonary Venous Isolation for Persistent Atrial Fibrillation
A study testing Traditional pulmonary vein isolation (PVI) ablation and Bachmann bundle modification in people with Persistent Atrial Fibrillation, run by Shenyang Northern Hospital.
Trial summary
This study is a prospective, randomized controlled, single-blind, multicenter study design. To evaluate the safety and efficacy of traditional pulmonary vein isolation (PVI) alone and PVI combined with Bachmann bundle ablation on persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Traditional pulmonary vein isolation (PVI) ablation and Bachmann bundle modification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects≥ 18 years old and ≤ 75 years old;
- the subject was diagnosed with persistent atrial fibrillation (duration of ≥6 months and ≤ 3 years);
- Able to understand the purpose of the trial, voluntarily participate in this study, the subject or his legal representative signed the informed consent form, and was willing to complete the follow-up according to the requirements of the protocol.
Who cannot join
- Previous atrial fibrillation catheter ablation therapy, left atrial appendage closure or atrial fibrillation surgery;
- atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible disease, or non-cardiac causes;
- Left atrial or left atrial appendage thrombus (confirmed by esophageal ultrasound or CT examination);
- Patients with pulmonary vein stenosis or pulmonary vein stents implanted;
- Have had atrial septal repair or atrial myxoma;
- Severe structural heart disease (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease);
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- Cardiac ultrasound showed that the diameter of the left atrium was ≥50mm
- New York College of Cardiology (NYHA) cardiac function grades III and IV; LVEF<40%；
- Those with cerebrovascular diseases (including stroke, transient ischemic attack) in the past 3 months;
- Those who have had cardiovascular events in the past 3 months (including acute myocardial infarction, coronary intervention or heart bypass);
- surgery, prosthetic valve replacement or repair, atrial or ventriculotomy;
- Those with acute or severe systemic infection;
- Combined with severe liver and kidney insufficiency (AST or ALT≥ 3 times the upper limit of normal; SCr>3.5mg/dl or Ccr<30ml/min);
- Those with obvious bleeding tendency and hematologic diseases, or contraindications to anticoagulation;
- Patients with malignant tumors and end-stage diseases with a life expectancy of < 12 months; After chemotherapy or radiotherapy for malignant tumors;
- The subject is a female who is pregnant or lactating or cannot use contraception during the trial;
- The subject has participated in clinical trials of other drugs or devices during the same period;
- Abnormalities or diseases that, in the opinion of the investigator, should be excluded from the scope of enrollment in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Study of Circumferential Pulmonary Venous Isolation Combined With Bachmann Bundle Modification Versus Circumferential Pulmonary Venous Isolation for Persistent Atrial Fibrillation
This study is a prospective, randomized controlled, single-blind, multicenter study design. To evaluate the safety and efficacy of traditional pulmonary vein isolation (PVI) alone and PVI combined with Bachmann bundle ablation on persistent atrial fibrillation.
According to the treatment strategy, they were divided into two groups. Control group: circumferential PVI alone group (CPVI). Experimental group: CPVI combined with Bachmann bundle ablation group (CPVI-BBM).
Read the detailed description
Catheter ablation enhances the likelihood of maintaining sinus rhythm in patients with atrial fibrillation (AF); however, the procedural success rate remains suboptimal in individuals with persistent AF. Research indicates that the Bachmann bundle plays a significant role in the initiation and maintenance of AF. In a study utilizing a porcine model, Schwartzman et al. demonstrated that ablation at various sites within the right atrial septum-specifically, the fossa ovalis, the crista terminalis of the right atrium, and the coronary sinus ostium-can effectively disrupt left-right atrial conduction. This disruption occurs without impairing the conduction function of the atrioventricular node or inducing other atrial arrhythmias, although it does result in the cessation of electrical and mechanical activity in the left atrium. Kumagai et al. conducted radiofrequency ablation on the central portion of the Bachmann bundle on the epicardial surface of the canine heart, successfully blocking interatrial conduction and terminating AF. Electrophysiological mapping revealed an absence of activation entering the right atrium from the Bachmann bundle, and no evidence of the Bachmann bundle's involvement in the formation of a reentry loop was observed.This study seeks to examine the safety, efficacy, and long-term outcomes associated with the integration of circumferential pulmonary vein isolation (CPVI) and Bachmann bundle ablation in the management of persistent atrial fibrillation. Participants were allocated into two distinct groups based on the treatment strategy: the control group, which received pulmonary vein isolation alone (CPVI), and the experimental group, which underwent a combination of pulmonary vein isolation and Bachmann bundle ablation (CPVI-BBM).
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Traditional pulmonary vein isolation (PVI) ablation, Bachmann bundle modification
- Keywords
- Circumferential pulmonary venous isolation, Bachmann bundle modification
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional pulmonary vein isolation (PVI) ablationProcedure or surgery
Traditional pulmonary vein isolation (PVI) ablation
Bachmann bundle modificationProcedure or surgery
Bachmann bundle modification
| Study group | Role | What they receive |
|---|---|---|
| CPVI-BBM | Experimental | Annular pulmonary vein electrical isolation combined with Bachmann bundle modification (CPVI-BBM) Receives: Procedure: Traditional pulmonary vein isolation (PVI) ablation; Procedure: Bachmann bundle modification |
| CPVI | Active comparator | Circumferential pulmonary venous isolation (CPVI) Receives: Procedure: Traditional pulmonary vein isolation (PVI) ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus rhythm maintenance rate after ablation in the CPVI group and CPVI-BBM group at 1 year.
Measured: 1year
Secondary outcomes (14)
Immediate success rate of surgery
Measured: Intra-procedure
Direct termination rate of intraoperative atrial fibrillation
Measured: Intra-procedure
The number of cardioversions
Measured: Intra-procedure
Total operative time (defined as the total time from the first femoral venous puncture to the final catheter removal)
Measured: Total operative time
Left atrial operation time (i.e., the time from the time when the ablation catheter enters the left atrium to the time it is evacuated from the left atrium)
Measured: Left atrial operation time
Ablation time, including total ablation time, CPVI ablation time, and BBM ablation time
Measured: Ablation time
X-ray exposure time
X-ray exposure time, including total exposure time, CPVI exposure time, and BBM exposure time
Measured: X-ray exposure time
X-ray exposure dose
X-ray exposure dose, including total exposure dose, CPVI exposure dose, and BBM exposure dose
Measured: intra-procedure
The area and volume of the left atrium
Calculate the area and volume of the left atrium in preparation for cardiac radiofrequency ablation
Measured: intra-procedure
The area of double ring vein isolation after catheter ablation, and the proportion of the area of the pulmonary vein isolation area to the left atrial surface area
Determine the area of double ring vein isolation following catheter ablation, as well as the ratio of the pulmonary vein isolation area to the total surface area of the left atrium.
Measured: Intra-procedure
Whether and to what extent the atrial appendage potential is delayed under postoperative sinus rhythm
Measured: Intra-procedure
Record whether to give stromal mapping ablation under sinus law; whether there is a combination of atrial prematurity/atrial tachycardia and ablation site; whether other linear ablation/alcohol ablation is given and the ablation site
Measured: Intra-procedure
Early atrial fibrillation recurrence was detected by ambulatory ECG during the 3-month follow-up period after surgery; recurrence of atrial fibrillation, atrial flutter and other atrial arrhythmias during 1 and 3 years of follow-up after surgery
Measured: 3 month, 1 year and 3 years of follow-up after surgery
Intraoperative and postoperative complication rates
Intraoperative and postoperative complication rates, complications include: atrial esophageal fistula, pulmonary vein stenosis, cardiac tamponade/perforation, death, phrenic nerve palsy, myocardial infarction, pericarditis (pericardial effusion leading to hemodynamic damage or requiring pericardiocentesis; prolonged hospital stay for more than 48 hours; Requires hospitalization; post-ablation effusion lasting more than 30 days), stroke or transient ischemic attack (TIA), vagus nerve injury, severe vascular access complications.
Measured: From surgery to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Zulu, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445360
- Sponsor's protocol ID
- SYNH-Y2024048
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Teuwen CP, Does LJMEV, Kik C, Mouws EMJP, Lanters EAH, Knops P, Taverne YJHJ, Bogers AJJC, de Groot NMS. Sinus Rhythm Conduction Properties across Bachmann's Bundle: Impact of Underlying Heart Disease and Atrial Fibrillation. J Clin Med. 2020 Jun 16;9(6):1875. doi: 10.3390/jcm9061875.
PubMed 32560096van Staveren LN, van der Does WFB, Heida A, Taverne YJHJ, Bogers AJJC, de Groot NMS. AF Inducibility Is Related to Conduction Abnormalities at Bachmann's Bundle. J Clin Med. 2021 Nov 26;10(23):5536. doi: 10.3390/jcm10235536.
PubMed 34884237
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Study of Circumferential Pulmonary Venous Isolation Combined With Bachmann Bundle Modification Versus Circumferential Pulmonary Venous Isolation for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07445360
- Acronym / sponsor ID
- SYNH-Y2024048
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Circumferential pulmonary venous isolation, Bachmann bundle modification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Mar 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 study is a prospective, randomized controlled, single-blind, multicenter study design. To evaluate the safety and efficacy of traditional pulmonary vein isolation (PVI) alone and PVI combined with Bachmann bundle ablation on persistent atrial fibrillation.
According to the treatment strategy, they were divided into two groups. Control group: circumferential PVI alone group (CPVI). Experimental group: CPVI combined with Bachmann bundle ablation group (CPVI-BBM).
Detailed description
Catheter ablation enhances the likelihood of maintaining sinus rhythm in patients with atrial fibrillation (AF); however, the procedural success rate remains suboptimal in individuals with persistent AF. Research indicates that the Bachmann bundle plays a significant role in the initiation and maintenance of AF. In a study utilizing a porcine model, Schwartzman et al. demonstrated that ablation at various sites within the right atrial septum-specifically, the fossa ovalis, the crista terminalis of the right atrium, and the coronary sinus ostium-can effectively disrupt left-right atrial conduction. This disruption occurs without impairing the conduction function of the atrioventricular node or inducing other atrial arrhythmias, although it does result in the cessation of electrical and mechanical activity in the left atrium. Kumagai et al. conducted radiofrequency ablation on the central portion of the Bachmann bundle on the epicardial surface of the canine heart, successfully blocking interatrial conduction and terminating AF. Electrophysiological mapping revealed an absence of activation entering the right atrium from the Bachmann bundle, and no evidence of the Bachmann bundle's involvement in the formation of a reentry loop was observed.This study seeks to examine the safety, efficacy, and long-term outcomes associated with the integration of circumferential pulmonary vein isolation (CPVI) and Bachmann bundle ablation in the management of persistent atrial fibrillation. Participants were allocated into two distinct groups based on the treatment strategy: the control group, which received pulmonary vein isolation alone (CPVI), and the experimental group, which underwent a combination of pulmonary vein isolation and Bachmann bundle ablation (CPVI-BBM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPVI-BBM | Experimental | Procedure: Traditional pulmonary vein isolation (PVI) ablation, Procedure: Bachmann bundle modificationAnnular pulmonary vein electrical isolation combined with Bachmann bundle modification (CPVI-BBM) |
| CPVI | Active comparator | Procedure: Traditional pulmonary vein isolation (PVI) ablationCircumferential pulmonary venous isolation (CPVI) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects≥ 18 years old and ≤ 75 years old;
- the subject was diagnosed with persistent atrial fibrillation (duration of ≥6 months and ≤ 3 years);
- Able to understand the purpose of the trial, voluntarily participate in this study, the subject or his legal representative signed the informed consent form, and was willing to complete the follow-up according to the requirements of the protocol.
Key exclusion criteria (18 listed)
- Previous atrial fibrillation catheter ablation therapy, left atrial appendage closure or atrial fibrillation surgery;
- atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible disease, or non-cardiac causes;
- Left atrial or left atrial appendage thrombus (confirmed by esophageal ultrasound or CT examination);
- Patients with pulmonary vein stenosis or pulmonary vein stents implanted;
- Have had atrial septal repair or atrial myxoma;
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 |
|---|---|---|
| Traditional pulmonary vein isolation (PVI) ablationTraditional pulmonary vein isolation (PVI) ablation | Procedure or surgery | CPVI, CPVI-BBM |
| Bachmann bundle modificationBachmann bundle modification | Procedure or surgery | CPVI-BBM |
Primary outcome
Sinus rhythm maintenance rate after ablation in the CPVI group and CPVI-BBM group at 1 year.
Time frame: 1year
14 secondary outcomes
Immediate success rate of surgery
Time frame: Intra-procedure
Direct termination rate of intraoperative atrial fibrillation
Time frame: Intra-procedure
The number of cardioversions
Time frame: Intra-procedure
Total operative time (defined as the total time from the first femoral venous puncture to the final catheter removal)
Time frame: Total operative time
Left atrial operation time (i.e., the time from the time when the ablation catheter enters the left atrium to the time it is evacuated from the left atrium)
Time frame: Left atrial operation time
Ablation time, including total ablation time, CPVI ablation time, and BBM ablation time
Time frame: Ablation time
X-ray exposure time
Time frame: X-ray exposure time
X-ray exposure dose
Time frame: intra-procedure
The area and volume of the left atrium
Time frame: intra-procedure
The area of double ring vein isolation after catheter ablation, and the proportion of the area of the pulmonary vein isolation area to the left atrial surface area
Time frame: Intra-procedure
Whether and to what extent the atrial appendage potential is delayed under postoperative sinus rhythm
Time frame: Intra-procedure
Record whether to give stromal mapping ablation under sinus law; whether there is a combination of atrial prematurity/atrial tachycardia and ablation site; whether other linear ablation/alcohol ablation is given and the ablation site
Time frame: Intra-procedure
Early atrial fibrillation recurrence was detected by ambulatory ECG during the 3-month follow-up period after surgery; recurrence of atrial fibrillation, atrial flutter and other atrial arrhythmias during 1 and 3 years of follow-up after surgery
Time frame: 3 month, 1 year and 3 years of follow-up after surgery
Intraoperative and postoperative complication rates
Time frame: From surgery to 3 months after surgery
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 11 May 2026.
- Background: PubMed 32560096Teuwen CP, Does LJMEV, Kik C, Mouws EMJP, Lanters EAH, Knops P, Taverne YJHJ, Bogers AJJC, de Groot NMS. Sinus Rhythm Conduction Properties across Bachmann's Bundle: Impact of Underlying Heart Disease and Atrial Fibrillation. J Clin Med. 2020 Jun 16;9(6):1875. doi: 10.3390/jcm9061875.
- Background: PubMed 34884237van Staveren LN, van der Does WFB, Heida A, Taverne YJHJ, Bogers AJJC, de Groot NMS. AF Inducibility Is Related to Conduction Abnormalities at Bachmann's Bundle. J Clin Med. 2021 Nov 26;10(23):5536. doi: 10.3390/jcm10235536.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional pulmonary vein isolation (PVI) ablation and Bachmann bundle modification in people with Persistent Atrial Fibrillation, run by Shenyang Northern Hospital.
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 3 inclusion and 18 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: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ming Liang, PhD (+86-17790991573, lming000919@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinus rhythm maintenance rate after ablation in the CPVI group and CPVI-BBM group at 1 year. (time frame: 1year). 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 NCT07445360, which also lists 2 linked publications.
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 11 May 2026.