Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 1:48 AM
Study NCT ID:
NCT07487532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Preventing Atrial Arrhythmia Recurrence After Ablation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-01-27', 'size': 255020, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-03-17T13:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of Atrial Arrhythmia After Catheter Ablation', 'timeFrame': 'Up to 12 months after catheter ablation (excluding a 3-month blanking period)', 'description': 'Recurrence of atrial arrhythmia, defined as atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds after a 3-month blanking period, detected by 12-lead electrocardiogram or 24-hour Holter monitoring and adjudicated by blinded electrophysiologists.'}], 'secondaryOutcomes': [{'measure': 'Change in Left Atrial Diameter', 'timeFrame': 'Baseline and 12 months after catheter ablation'}, {'measure': 'Change in Left Ventricular End-Diastolic Diameter', 'timeFrame': 'Baseline and 12 months after catheter ablation'}, {'measure': 'Change in Left Ventricular End-Systolic Diameter', 'timeFrame': 'Baseline and 12 months after catheter ablation'}, {'measure': 'Change in Left Ventricular Ejection Fraction', 'timeFrame': 'Baseline and 12 months after catheter ablation'}, {'measure': 'Change in Atrial Fibrillation Burden', 'timeFrame': 'Baseline and 12 months after catheter ablation'}, {'measure': 'Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score', 'timeFrame': 'Baseline, and 1, 3, 6, and 12 months after catheter ablation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate whether acupuncture can reduce the recurrence of atrial arrhythmias after catheter ablation in patients with persistent atrial fibrillation. Catheter ablation is an effective treatment for atrial fibrillation, but recurrence remains common, especially in persistent cases.\n\nIn this prospective, randomized, open-label trial, 120 patients with persistent atrial fibrillation who have undergone successful catheter ablation will be enrolled and randomly assigned to two groups. The intervention group will receive acupuncture in addition to standard medical therapy, while the control group will receive standard medical therapy alone.\n\nParticipants will be followed for 12 months. The primary outcome is the recurrence of atrial arrhythmias, including atrial fibrillation, atrial flutter, or atrial tachycardia. Secondary outcomes include cardiac structure and function, atrial fibrillation burden, and quality of life.\n\nThis study will provide clinical evidence on whether acupuncture can be an effective adjunctive therapy to improve outcomes after catheter ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20 to 75 years Persistent atrial fibrillation Undergoing first-time catheter ablation with successful restoration of sinus rhythm Left atrial diameter \\<50 mm Able to understand the study and provide written informed consent\n\nExclusion Criteria:\n\n* Cardiovascular events within the past 3 months (including stroke, transient ischemic attack, myocardial infarction, unstable angina, or cardiac surgery) Symptomatic hypotension with systolic blood pressure \\<100 mmHg on two consecutive measurements Severe valvular heart disease or other significant structural heart disease Pregnancy, breastfeeding, or planned pregnancy during the study period History of pacemaker implantation Second- or third-degree atrioventricular block Bifascicular or trifascicular block Acupuncture treatment for cardiovascular disease within the past 3 months\n\nSevere comorbid conditions, including:\n\nMalignant tumors Chronic infectious diseases Severe renal dysfunction (eGFR \\<30 mL/min/1.73 m² or requiring dialysis) Moderate to severe liver dysfunction (Child-Pugh class B or C) Anemia (hemoglobin \\<90 g/L) Systemic diseases requiring steroid therapy Severe cognitive impairment or dementia Alcohol or substance abuse Life expectancy \\<12 months Poor compliance or inability to provide informed consent Participation in another interventional clinical study'}, 'identificationModule': {'nctId': 'NCT07487532', 'briefTitle': 'Acupuncture for Preventing Atrial Arrhythmia Recurrence After Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Effectiveness of Acupuncture for Atrial Tachyarrhythmia Prevention After Catheter Ablation in Persistent Atrial Fibrillation Patients: a Prospective, Open-label, Randomized, Blank-controlled Trial', 'orgStudyIdInfo': {'id': 'B2026-077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture Plus Standard Therapy', 'interventionNames': ['Procedure: Electroacupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Therapy Alone', 'interventionNames': ['Drug: Standard Medical Therapy']}], 'interventions': [{'name': 'Electroacupuncture', 'type': 'PROCEDURE', 'description': 'Electroacupuncture is administered starting on the second day after catheter ablation. Treatment is performed twice weekly for 5 weeks using bilateral Neiguan (PC6) and Jianshi (PC5) acupoints. Low-frequency electrical stimulation (2 Hz) is applied during each session. All procedures are performed by trained practitioners following standardized protocols.', 'armGroupLabels': ['Acupuncture Plus Standard Therapy']}, {'name': 'Standard Medical Therapy', 'type': 'DRUG', 'description': 'Standard medical therapy is administered after catheter ablation according to current clinical guidelines and physician judgment. This includes antiarrhythmic drugs and anticoagulation therapy as appropriate. Medication use is recorded throughout the study period.', 'armGroupLabels': ['Standard Therapy Alone']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}