Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:30 AM
Study NCT ID:
NCT07445360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circumferential Pulmonary Venous Isolation Combined With Bachmann Bundle Modification Versus Circumferential Pulmonary Venous Isolation for Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sinus rhythm maintenance rate after ablation in the CPVI group and CPVI-BBM group at 1 year.', 'timeFrame': '1year'}], 'secondaryOutcomes': [{'measure': 'Immediate success rate of surgery', 'timeFrame': 'Intra-procedure'}, {'measure': 'Direct termination rate of intraoperative atrial fibrillation', 'timeFrame': 'Intra-procedure'}, {'measure': 'The number of cardioversions', 'timeFrame': 'Intra-procedure'}, {'measure': 'Total operative time (defined as the total time from the first femoral venous puncture to the final catheter removal)', 'timeFrame': 'Total operative time'}, {'measure': '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)', 'timeFrame': 'Left atrial operation time'}, {'measure': 'Ablation time, including total ablation time, CPVI ablation time, and BBM ablation time', 'timeFrame': 'Ablation time'}, {'measure': 'X-ray exposure time', 'timeFrame': 'X-ray exposure time', 'description': 'X-ray exposure time, including total exposure time, CPVI exposure time, and BBM exposure time'}, {'measure': 'X-ray exposure dose', 'timeFrame': 'intra-procedure', 'description': 'X-ray exposure dose, including total exposure dose, CPVI exposure dose, and BBM exposure dose'}, {'measure': 'The area and volume of the left atrium', 'timeFrame': 'intra-procedure', 'description': 'Calculate the area and volume of the left atrium in preparation for cardiac radiofrequency ablation'}, {'measure': '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', 'timeFrame': 'Intra-procedure', 'description': '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.'}, {'measure': 'Whether and to what extent the atrial appendage potential is delayed under postoperative sinus rhythm', 'timeFrame': 'Intra-procedure'}, {'measure': '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', 'timeFrame': 'Intra-procedure'}, {'measure': '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', 'timeFrame': '3 month, 1 year and 3 years of follow-up after surgery'}, {'measure': 'Intraoperative and postoperative complication rates', 'timeFrame': 'From surgery to 3 months after surgery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circumferential pulmonary venous isolation', 'Bachmann bundle modification'], 'conditions': ['Persistent Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '32560096', 'type': 'BACKGROUND', 'citation': "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': '34884237', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nAccording 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).', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects≥ 18 years old and ≤ 75 years old;\n2. the subject was diagnosed with persistent atrial fibrillation (duration of ≥6 months and ≤ 3 years);\n3. 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.\n\nExclusion Criteria:\n\n1. Previous atrial fibrillation catheter ablation therapy, left atrial appendage closure or atrial fibrillation surgery;\n2. atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible disease, or non-cardiac causes;\n3. Left atrial or left atrial appendage thrombus (confirmed by esophageal ultrasound or CT examination);\n4. Patients with pulmonary vein stenosis or pulmonary vein stents implanted;\n5. Have had atrial septal repair or atrial myxoma;\n6. Severe structural heart disease (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease);\n7. Cardiac ultrasound showed that the diameter of the left atrium was ≥50mm\n8. New York College of Cardiology (NYHA) cardiac function grades III and IV; LVEF\\<40%；\n9. Those with cerebrovascular diseases (including stroke, transient ischemic attack) in the past 3 months;\n10. Those who have had cardiovascular events in the past 3 months (including acute myocardial infarction, coronary intervention or heart bypass);\n11. surgery, prosthetic valve replacement or repair, atrial or ventriculotomy;\n12. Those with acute or severe systemic infection;\n13. 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);\n14. Those with obvious bleeding tendency and hematologic diseases, or contraindications to anticoagulation;\n15. Patients with malignant tumors and end-stage diseases with a life expectancy of \\< 12 months; After chemotherapy or radiotherapy for malignant tumors;\n16. The subject is a female who is pregnant or lactating or cannot use contraception during the trial;\n17. The subject has participated in clinical trials of other drugs or devices during the same period;\n18. Abnormalities or diseases that, in the opinion of the investigator, should be excluded from the scope of enrollment in this study.'}, 'identificationModule': {'nctId': 'NCT07445360', 'briefTitle': 'Circumferential Pulmonary Venous Isolation Combined With Bachmann Bundle Modification Versus Circumferential Pulmonary Venous Isolation for Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Shenyang Northern Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SYNH-Y2024048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPVI-BBM', 'description': 'Annular pulmonary vein electrical isolation combined with Bachmann bundle modification (CPVI-BBM)', 'interventionNames': ['Procedure: Traditional pulmonary vein isolation (PVI) ablation', 'Procedure: Bachmann bundle modification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CPVI', 'description': 'Circumferential pulmonary venous isolation (CPVI)', 'interventionNames': ['Procedure: Traditional pulmonary vein isolation (PVI) ablation']}], 'interventions': [{'name': 'Traditional pulmonary vein isolation (PVI) ablation', 'type': 'PROCEDURE', 'description': 'Traditional pulmonary vein isolation (PVI) ablation', 'armGroupLabels': ['CPVI', 'CPVI-BBM']}, {'name': 'Bachmann bundle modification', 'type': 'PROCEDURE', 'description': 'Bachmann bundle modification', 'armGroupLabels': ['CPVI-BBM']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ming Liang, PhD', 'role': 'CONTACT', 'email': 'lming000919@sina.com', 'phone': '+86-17790991573'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Northern Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, clinical professor', 'investigatorFullName': 'Wang Zulu', 'investigatorAffiliation': 'Shenyang Northern Hospital'}}}}