Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 6:09 PM
Study NCT ID:
NCT04942834
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'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': 'D013015', 'term': 'Sotalol'}, {'id': 'D000077764', 'term': 'Dronedarone'}, {'id': 'D000638', 'term': 'Amiodarone'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 286}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-06-20', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment success at 12 months', 'timeFrame': 'Randomization to 12 months', 'description': 'Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing cryoballoon catheter measured by freedom from AF recurrence following a 3-month period after the index ablation or AAD initiation.'}, {'measure': 'Rate of serious adverse events', 'timeFrame': 'Randomization to 12 months', 'description': 'Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure'}], 'secondaryOutcomes': [{'measure': 'Quality of life changes at 12 months measured by AFEQT', 'timeFrame': 'one year', 'description': 'The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by AF Quality of Life Survey (AFEQT)'}, {'measure': 'Quality of life changes at 12 months measured by SF-12', 'timeFrame': 'one year', 'description': 'The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by 12-Item Short Form Survey (SF-12)'}, {'measure': 'Arrhythmia recurrence during blanking period', 'timeFrame': '3 months', 'description': 'atrial tachycardia recurrence rate during the blanking period'}, {'measure': 'time to first time cardiovascular hospitalization (month)', 'timeFrame': 'one year', 'description': 'time to first time cardiovascular hospitalization after treatment (month)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryoablation', 'pulmonary vein isolation', 'atrial fibrillation', 'Anti-Arrhythmic Agents'], 'conditions': ['Atrial Fibrillation, Persistent', 'Arrhythmias, Cardiac']}, 'descriptionModule': {'briefSummary': 'This study is to assess the effectiveness and safety of using cryoballoon ablation comparing with anti-arrhythmic drug therapy as initial treatment for naive patients with persistent atrial fibrillation.', 'detailedDescription': 'Subjects with persistent atrial fibrillation with no history of treatment with anti-arrhythmic drugs are randomized 1:1 to either an anti-arrhythmic drug or pulmonary vein isolation using the cryoballoon catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 1 year documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 1 year documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF\n* Age 18 -75 years old\n* Structurally normal heart with LVEF ≥50%, interventricular septum thickness ≤ 12 mm, and left atrial diameter \\<46 mm (short axis) as obtained by transthoracic echocardiography. •\n* Normal ECG parameters when measured in sinus rhythm (QRS width ≤120 ms in a 12-channel surface ECG, QTc interval \\<440 ms, and PQ interval ≤210 ms).\n\nExclusion Criteria:\n\n* History of AF treatment with class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.\n* left atrial ablation or surgical procedure (including left atrial appendage closures)\n* Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months\n* Presence of any pulmonary vein stents\n* Presence of any pre-existing pulmonary vein stenosis\n* Pre-existing hemidiaphragmatic paralysis\n* Presence of any cardiac valve prosthesis\n* +3 and +4 mitral valve regurgitation or stenosis\n* Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding e consent date\n* Unstable angina\n* New York Heart Association (NYHA) Class II, III or IV congestive heart failure\n* Primary pulmonary hypertension\n* Rheumatic heart disease\n* Thrombocytosis, thrombocytopenia\n* Any condition contraindicating chronic anticoagulation\n* Active systemic infection\n* Hypertrophic cardiomyopathy\n* Cryoglobulinemia\n* Uncontrolled hyperthyroidism\n* Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date\n* Any woman known to be pregnant or breastfeeding.\n* Life expectancy less than one year\n* Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic\n* Active intracardiac thrombus\n* Known drug or alcohol dependency\n* Unwilling or unable to comply fully with study procedures and follow-up\n* Significant Chronic Kidney Disease-estimated Glomerular Filtration Rate(CKD-eGFR) \\<30umol/L'}, 'identificationModule': {'nctId': 'NCT04942834', 'acronym': 'Cryo-InitialAF', 'briefTitle': 'Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs', 'orgStudyIdInfo': {'id': 'Cryo-initial-AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drug treatment group', 'description': 'receive class I or class III AAD to restore or maintain sinus rhythm.', 'interventionNames': ['Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone']}, {'type': 'EXPERIMENTAL', 'label': 'cryoballoon ablation group', 'description': 'receive cryoballoon ablation to restore sinus rhythm.', 'interventionNames': ['Device: cryoballoon ablation']}], 'interventions': [{'name': 'Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone', 'type': 'DRUG', 'description': 'Class I or III antiarrhythmic drug, including sotalol', 'armGroupLabels': ['Drug treatment group']}, {'name': 'cryoballoon ablation', 'type': 'DEVICE', 'description': 'Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)', 'armGroupLabels': ['cryoballoon ablation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Chen, M.D.', 'role': 'CONTACT', 'email': 'fjslchenlin@163.com', 'phone': '86-13509399209'}], 'facility': 'Fujian Provincial Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '523018', 'city': 'Dongguan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Suxia Guo, M.D.', 'role': 'CONTACT', 'email': 'guo7771812@163.com', 'phone': '86-13665103927'}], 'facility': "Dongguan People's Hospital", 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingfeng Wang, M.D.', 'role': 'CONTACT', 'email': 'wangjingfeng2017@163.com', 'phone': '13688872453'}], 'facility': 'Sun Yat-sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '511466', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiangui He, M.D.', 'role': 'CONTACT', 'email': 'hejiangui@163.com', 'phone': '86-18902233622'}], 'facility': 'The First Affiliated Hospital,Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '561113', 'city': 'Guiyang', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Li, M.D.', 'role': 'CONTACT', 'email': 'Liwei249188@sina.com', 'phone': '86-13809482491'}], 'facility': 'The Affiliated Hospital Of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Xu, M.D.', 'role': 'CONTACT', 'email': '13390900868@163.com', 'phone': '86-13390900868'}], 'facility': 'Nanjing Drum Tower hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Genshan Ma, M.D.', 'role': 'CONTACT', 'email': 'magenshan@holmail.com', 'phone': '86-13002580569'}], 'facility': 'Zhongda Hospital Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '226019', 'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Lu, M.D.', 'role': 'CONTACT', 'email': 'luqint@sina.com', 'phone': '86-13962989292'}], 'facility': 'Affiliated Hospital Of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '225300', 'city': 'Taizhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongbao Ruan, M.D.', 'role': 'CONTACT', 'email': 'tzcardiac@163.com', 'phone': '86-13401238518'}], 'facility': "Jiangsu Taizhou People's Hospital", 'geoPoint': {'lat': 32.49069, 'lon': 119.90812}}, {'zip': '221009', 'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bing Han, M.D.', 'role': 'CONTACT', 'email': '332595105@qq.com', 'phone': '86-15305218127'}], 'facility': 'Xuzhou Central Hospital', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingquan Zhong, M.D.', 'role': 'CONTACT', 'email': '18560086597@163.com', 'phone': '18560086597'}], 'facility': 'Qilu Hospital Of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li-qun Wu, MD,PhD', 'role': 'CONTACT', 'email': 'wuliqun89@hotmail.com', 'phone': '+8613801621534'}, {'name': 'Yangyang Bao, MD,PhD', 'role': 'CONTACT', 'email': '575525677@qq.com', 'phone': '+8613301687572'}, {'name': 'Li-qun Wu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yangyang Bao, MD,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yawei Xu, M.D.', 'role': 'CONTACT', 'email': 'xuyawei@tongji.edu.cn', 'phone': '86-18917683030'}], 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rui Zeng, M.D.', 'role': 'CONTACT', 'email': 'zengrui_0524@126.com', 'phone': '86-18980606560'}], 'facility': '"West China School of Medicine /West China Hospital of Sichuan University "', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300022', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Xu', 'role': 'CONTACT', 'email': 'DrXuJing@163.com', 'phone': '86-13920107549'}], 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300211', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangping Li, M.D.', 'role': 'CONTACT', 'email': 'Tjcardiol@126.com', 'phone': '86-13820289800'}], 'facility': 'The Second Hospital Of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '830054', 'city': 'Ürümqi', 'state': 'Xinjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Baopeng Tang, M.D.', 'role': 'CONTACT', 'email': 'tangbaopeng1111@163.com', 'phone': '86-13579881111'}], 'facility': 'The First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}], 'centralContacts': [{'name': 'Li-qun Wu, MD,PhD', 'role': 'CONTACT', 'email': 'wuliqun89@hotmail.com', 'phone': '+8613801621534'}, {'name': 'Yangyang Bao, MD,PhD', 'role': 'CONTACT', 'email': '575525677@qq.com', 'phone': '+8613301687572'}], 'overallOfficials': [{'name': 'Li-qun Wu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}