Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-28 @ 2:06 AM
Study NCT ID:
NCT06742866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-19
First Post:
2024-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000638', 'term': 'Amiodarone'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 418}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of atrial arrhythmia lasting more than 30 seconds.', 'timeFrame': 'At least 12 months of follow-up, beyond the initial 3 month blanking period', 'description': 'After a single ablation procedure, with at least 12 months of follow-up, any atrial arrhythmia recorded for more than 30 seconds - including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - occurring beyond the initial 3-month blanking period.'}], 'secondaryOutcomes': [{'measure': 'Recurrence of atrial fibrillation (AF) lasting more than 30 seconds.', 'timeFrame': 'At least 12 months of follow-up, beyond the initial 3 month blanking period', 'description': 'After a single ablation procedure, with at least 12 months of follow-up, any atrial arrhythmia recorded for more than 30 seconds - including atrial fibrillation (AF) - occurring beyond the initial 3-month blanking period.'}, {'measure': 'Recurrence of atrial arrhythmias during the 3-month blanking period after atrial fibrillation (AF) surgery.', 'timeFrame': 'During the 3-month blanking period after atrial fibrillation (AF) surgery', 'description': 'Recurrence of atrial arrhythmias during the 3-month blanking period after atrial fibrillation (AF) surgery.'}, {'measure': 'hospital readmission for re-ablation, electrical cardioversion and adverse drug events (ADEs)', 'timeFrame': 'At least 12 months of follow-up', 'description': 'During the follow-up period, hospital readmission for re-ablation, electrical cardioversion and adverse drug events (ADEs), including bleeding, liver dysfunction, renal dysfunction, skin sensitivity, gastrointestinal adverse reactions, bradyarrhythmia (\\<55 bpm), ischemic stroke, and hyperthyroidism, etc.'}, {'measure': 'Quality of life assessment using AFEQT', 'timeFrame': 'At least 12 months of follow-up', 'description': 'Assessment of quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life Questionnaire) during at least 12 months of follow-up.'}, {'measure': 'Serum drug concentrations of amiodarone and its metabolite desethylamiodarone.', 'timeFrame': 'At 1 month and 3 months after surgery.', 'description': 'Serum drug concentrations of amiodarone and its metabolite desethylamiodarone at 1 month and 3 months after surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the efficacy and safety of intravenous combined with oral amiodarone in preventing atrial fibrillation (AF) recurrence after catheter ablation in patients with persistent atrial fibrillation. Using a randomized controlled trial design, patients will be divided into two groups: intravenous + oral amiodarone and oral amiodarone alone. Through multiple follow-ups at 1, 3, 6, and 12 months post-procedure, the study will compare the two treatment regimens in terms of blood concentrations of amiodarone and its metabolites, efficacy (short-term recurrence \\[SR\\], long-term recurrence \\[LR\\], and patient quality of life), and safety (adverse drug reactions). Subgroup analyses will also be conducted to explore potential differences in drug treatment effects among populations with varying risk factors. This study aims to provide valuable clinical data for post-ablation management of atrial fibrillation, contributing to the development of optimized treatment strategies to enhance therapeutic outcomes and improve patient quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged ≥18 years;\n* First-time catheter ablation for persistent atrial fibrillation (defined as any - previous episode lasting ≥7 days);\n* Symptomatic atrial fibrillation patients who have failed or are intolerant to at least one class I or III antiarrhythmic drug;\n* Participants who are able to understand the purpose of the study, voluntarily agree to participate, and provide written informed consent.\n\nExclusion Criteria:\n\n* Those unwilling or unsuitable to restart or continue antiarrhythmic drug therapy;\n* Life expectancy \\< 12 months;\n* Severe liver or kidney dysfunction;\n* Allergy to amiodarone components;\n* Pregnant or breastfeeding women;\n* Contraindications to amiodarone (e.g., blood pressure \\< 90/60 mmHg; bradycardia \\< 55 bpm, second- or third-degree AV block, or sick sinus syndrome);\n* Thyroid disorders, such as hyperthyroidism or hypothyroidism.'}, 'identificationModule': {'nctId': 'NCT06742866', 'briefTitle': 'Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'The Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'ITAD-PAF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group (Intravenous + Oral Amiodarone)', 'description': 'Within 24 hours post-operation, patients will receive an intravenous amiodarone loading dose of 300 mg QD along with oral amiodarone 200 mg BID. This regimen will be continued for 3 days, after which intravenous amiodarone will be discontinued, and oral amiodarone 200 mg BID will be continued for 3 months.', 'interventionNames': ['Drug: Amiodarone Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group (Oral Amiodarone only)', 'description': 'Postoperatively, instead of administering intravenous amiodarone, sodium chloride injection was used as a placebo, and oral amiodarone 200 mg BID was directly given for 3 months.', 'interventionNames': ['Drug: Sodium Chloride Injection 0.9%']}], 'interventions': [{'name': 'Amiodarone Injection', 'type': 'DRUG', 'description': 'Administer 300 mg of intravenous amiodarone as a loading dose once daily (QD) and 200 mg of oral amiodarone twice daily (BID) within 24 hours postoperatively, and continue for 3 consecutive days.', 'armGroupLabels': ['Experimental group (Intravenous + Oral Amiodarone)']}, {'name': 'Sodium Chloride Injection 0.9%', 'type': 'DRUG', 'description': 'Sodium chloride injection as a placebo in an amount equivalent to amiodarone injection.', 'armGroupLabels': ['Control group (Oral Amiodarone only)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Xuhui', 'country': 'China', 'contacts': [{'name': 'Shaohui Wu', 'role': 'CONTACT', 'email': 'wushaohui18@163.com', 'phone': '15821960839'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shaohui Wu', 'role': 'CONTACT', 'email': 'wushaohui18@163.com', 'phone': '15821960839'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xu Liu', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}