Circumferential Pulmonary Venous Isolation Combined With Bachmann Bundle Modification Versus Circumferential Pulmonary Venous Isolation for Persistent Atrial Fibrillation

NCT07445360 | Not Yet Recruiting

• 1 other identifier: SYNH-Y2024048
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Persistent Atrial Fibrillation

Keywords

Circumferential pulmonary venous isolation; Bachmann bundle modification

Outcome Measures

Primary Outcomes (1)

• Sinus rhythm maintenance rate after ablation in the CPVI group and CPVI-BBM group at 1 year.

  1year

Secondary Outcomes (14)

• Immediate success rate of surgery

  Intra-procedure

• Direct termination rate of intraoperative atrial fibrillation

  Intra-procedure

• The number of cardioversions

  Intra-procedure

• Total operative time (defined as the total time from the first femoral venous puncture to the final catheter removal)

  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)

  Left atrial operation time

Study Arms (2)

CPVI-BBM

EXPERIMENTAL

Annular pulmonary vein electrical isolation combined with Bachmann bundle modification (CPVI-BBM)

Procedure: Traditional pulmonary vein isolation (PVI) ablation; Procedure: Bachmann bundle modification

CPVI

ACTIVE COMPARATOR

Circumferential pulmonary venous isolation (CPVI)

Procedure: Traditional pulmonary vein isolation (PVI) ablation

Interventions

Traditional pulmonary vein isolation (PVI) ablation PROCEDURE

Traditional pulmonary vein isolation (PVI) ablation

CPVI; CPVI-BBM

Bachmann bundle modification PROCEDURE

Bachmann bundle modification

CPVI-BBM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Related Publications (2)

• 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.

  PMID: 32560096 BACKGROUND

• van 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.

  PMID: 34884237 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ming Liang, PhD

CONTACT

+86-17790991573; lming000919@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, clinical professor

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 3, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE