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NCT07445360Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 11 May 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
320 (estimated)
First submitted
16 Feb 2026
Start date
1 May 2026
Primary completion date
31 Dec 2028
Lead sponsor
Shenyang Northern Hospital
NCT number
NCT07445360

What you commit to

  • Study type: Interventional
  • Planned participants: 320
  • From 1 May 2026 to the primary completion date, 31 Dec 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous atrial fibrillation catheter ablation therapy, left atrial appendage closure or atrial fibrillation surgery;
  • surgery, prosthetic valve replacement or repair, atrial or ventriculotomy;
  • The subject has participated in clinical trials of other drugs or devices during the same period;

Other illness

  • atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible disease, or non-cardiac causes;
  • 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
  • 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);
  • Those with acute or severe systemic infection;
  • 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;
  • Abnormalities or diseases that, in the opinion of the investigator, should be excluded from the scope of enrollment in this study.

Lab values

  • New York College of Cardiology (NYHA) cardiac function grades III and IV; LVEF\<40%;
  • 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);

Other

  • 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;
  • The subject is a female who is pregnant or lactating or cannot use contraception during the trial;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.