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

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

Overview

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).

Interventions

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

Primary outcome measures

• Sinus rhythm maintenance rate after ablation in the CPVI group and CPVI-BBM group at 1 year. [Time frame: 1year]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 32560096
• 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

Identifiers

NCT: NCT07445360 · SYNH-Y2024048

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗