Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2025-12-26 @ 1:02 PM
Study NCT ID:
NCT07095959
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 340}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period', 'timeFrame': '12 months after procedure excluding the 2-month blanking period'}], 'secondaryOutcomes': [{'measure': 'Any atrial arrhythmias lasting ≥30s with or without AAD during 12 months after procedure excluding the 2-months blanking period', 'timeFrame': '12 months after procedure excluding the 2-months blanking period'}, {'measure': 'Any atrial flutter/atrial tachycardia lasting ≥30s during 12 months after procedure excluding the 2-months blanking period', 'timeFrame': '12 months after procedure excluding the 2-months blanking period'}, {'measure': 'Any atrial arrhythmias after multiple ablation with or without AADs', 'timeFrame': '12 months after first procedure excluding the 2-months blanking period'}, {'measure': 'AF burden', 'timeFrame': '12 months after procedure excluding the 2-months blanking period', 'description': 'Total AF/AFL time devided by total monitoring time'}, {'measure': 'procedural complications', 'timeFrame': '30 days after the procedure'}, {'measure': 'Change in quality of life', 'timeFrame': 'at baseline and 12 months after procedure', 'description': 'Assessed by AFEQT scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'The Marvel-PAF trial is an investigator initiated, multi-center, open-label, randomized trial, which aims to compare the effectiveness of vein of Marshall in addition to pulmonary vein isolation using pulsed field ablation in the treatment of paroxysmal atrial fibrillation. The primary endpoint is any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age over 18 years;\n2. With symptomatic\\* paroxysmal AF;\n3. Undergoing first AF ablation;\n4. At least one AF lasting over 30s documented by 12-lead ECG, Holter, or other rhythm monitoring device in the past 12 months;\n5. Able to understand the purpose of the study, willing to receive randomization of the ablation strategy, and able to be followed up as required, voluntarily participate in the study and signed a written informed consent.\n\n * Symptoms include but not restricted to palpitations, dizziness, fatigue, or shortness of breath and chest discomfort\n\nExclusion Criteria:\n\n1. Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation \\>7 days;\n2. Thrombosis in the heart cavity;\n3. Contraindications to oral anticoagulants including the presence of a history of heparin-induced thrombocytopenia;\n4. Transient/reversible atrial fibrillation due to electrolyte disorders, thyroid disease or other non-cardiac-related causes;\n5. Acute coronary syndrome in the past 3 months or coronary intervention or coronary artery bypass treatment;\n6. Stroke or transient ischemic attacks (TIA) in the past 3 months;\n7. History of cardiac surgery or other surgical history involving left atrium, such as previous left atrial catheter ablation, atrial septal defect repair, etc.;\n8. History of previous severe valvular disease (severe mitral stenosis or regurgitation), congenital heart disease, hypertrophic cardiomyopathy or dilated cardiomyopathy;\n9. TEE examination in the past 12 months showed that the left atrium diameter of the parasternal long axis section was ≥55mm;\n10. Other factors that are not suitable for surgery (such as history of organ transplant surgery or ongoing evaluation of organ transplant surgery, life expectancy less than 1 year, uncontrolled cancer, pregnancy, breastfeeding, or planning to get pregnant, etc.);\n11. Other patients who were not suitable for enrollment in this study after the investigator's evaluation;"}, 'identificationModule': {'nctId': 'NCT07095959', 'acronym': 'MARVEL-PAF', 'briefTitle': 'Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'MARVEL-PAF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PFA-PVI + EIVOM group', 'description': 'PVI will be performed with PFA first, then EIVOM will be performed to achieve potential cardiac autonomous nerve modulation while reinforce LPV isolation.', 'interventionNames': ['Procedure: vein of Marshall ethanol infusion', 'Procedure: PVI using pulsed field ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PFA-PVI group', 'description': 'PVI will be performed with PFA only', 'interventionNames': ['Procedure: PVI using pulsed field ablation']}], 'interventions': [{'name': 'vein of Marshall ethanol infusion', 'type': 'PROCEDURE', 'description': 'After PFA, the coronary sinus venography will be acquired in search of VOM ostium. Then an over-the-wire balloon will be sent into the VOM and deflated with 4-6 atm. Selective VOM venography will be performed, followed by injection of 10ml 95% ethanol into the VOM.', 'armGroupLabels': ['PFA-PVI + EIVOM group']}, {'name': 'PVI using pulsed field ablation', 'type': 'PROCEDURE', 'description': 'Bilateral pulmonary vein antrum ablation using a pulsed field ablation', 'armGroupLabels': ['PFA-PVI + EIVOM group', 'PFA-PVI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Caihua Sang', 'role': 'CONTACT', 'email': 'sch9613070@sina.com', 'phone': '+86 010-81992280'}], 'facility': 'Beijing Anzhen Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Caihua Sang, MD', 'role': 'CONTACT', 'email': 'sch9613070@sina.com', 'phone': '+86 010-81992280'}, {'name': 'Yiwei Lai', 'role': 'CONTACT', 'email': 'yiweil0624@foxmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual data will be shared only upon reasonable request to the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive director of Arrhythmia center', 'investigatorFullName': 'Caihua Sang', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}