[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570152":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":7,"responsibleParty":22,"collaborators":7,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":7,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":33,"enrollmentInfo":34,"targetDuration":37,"studyType":38,"phases":7,"briefSummary":39,"conditions":40,"keywords":43,"overallStatus":46,"whyStopped":7,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":7},{"fullName":5,"class":6},"China National Center for Cardiovascular Diseases","OTHER_GOV",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","cryoablation","The therapeutic cryoablation agent used in this trial was liquid nitrogen with an evaporation temperature of -196°C, which was transported to the ablation pen through a vacuum line to exchange energy at the heart site to perform cryoablation.",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Zhe Zheng, MD,PhD","CONTACT","+86 10 8839 8265","zhengzhe@fuwai.com",{"name":20,"role":16,"phone":7,"phoneExt":7,"email":21},"Chunyu Yu, MD, PhD","yuchunyu@fuwai.com",{"type":23,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100570152","an-exploratory-clinical-study-to-evaluate-the-safety-and-efficacy-of-a-cardiac-surgical-cryoablation-system-for-the-treatment-of-atrial-fibrillation-100570152",false,"NCT06703528","An Exploratory Clinical Study to Evaluate the Safety and Efficacy of a Cardiac Surgical Cryoablation System for the Treatment of Atrial Fibrillation","Cryoablation System with Liquid Nitrogen for the Treatment of Atrial Fibrillation","Inclusion Criteria:\n\n* patients with valvular disease (e.g., mitral, tricuspid, and aortic valve disease) requiring surgical intervention;\n* patients with atrial fibrillation who consent to cryoablation;\n* 18-75 years of age (as of the date of signing the informed consent form);\n* signing the patient's informed consent.\n\nExclusion Criteria:\n\n* intracardiac thrombosis;\n* patients with absolute contraindications to anticoagulation;\n* combination of other cardiac diseases requiring surgical treatment;\n* patients with a diagnosis of coronary artery disease (coronary artery enhancement CT or coronary angiography suggesting that any one of the three coronary vessels and their major branches has a stenosis greater than or equal to 50%);\n* patients with generalized malignant disease or severe insufficiency of liver, kidney, heart and lung functions;\n* patients with current active infection;\n* pregnant and lactating patients;\n* patients with a prior history of cardiac surgery;\n* patients with myocardial infarction within the last 3 months;\n* patients who have suffered a stroke within the last 3 months;\n* patients with an anterior-posterior left atrial diameter greater than 70 mm;\n* left ventricular ejection fraction (LVEF) \\\u003C50%;\n* patients who are not expected to complete the 6-month postoperative follow-up;\n* those who are participating in other clinical trials and have not met the primary endpoint;\n* those who, in the opinion of the investigator, are not suitable for participation in this clinical study.","ALL","18 Years","75 Years",{"count":35,"type":36},10,"ESTIMATED","6 Months","OBSERVATIONAL","The goal of this prospective, observational study is to evaluate the safety and efficacy of a cardiac surgical cryoablation system for the treatment of atrial fibrillation. This study will be conducted at Fuwai Hospital in China. A total of 10 subjects with heart valve diseases (e.g., mitral, tricuspid, and aortic valve diseases) requiring surgical treatment and with atrial fibrillation will be enrolled in the study, and all of them will undergo surgical ablation using surgical cryoablation devices (cryoablation clamps and pens) with follow-up visits at 3 and 6 months after the procedure. In this study, the incidence of cardiac and cerebrovascular-related adverse events in the perioperative period and at 6 months after procedure is defined as the primary safety endpoint (all-cause mortality, stroke, systematic embolism, cardiac reoperations, heart failure requiring hospitalization, ablation-related coronary artery stenosis\u002Focclusion, pulmonary vein stenosis, and rate of permanent pacemaker implantation.). The primary efficacy endpoint is the probability of freedom from atrial tachyarrhythmias at 6 months after the procedure. Device ease of use, technical success, ablation procedure time, and assessment of the incidence of device defects are defined as secondary endpoints.",[41,42],"Atrial Fibrillation (AF)","Heart Valve Diseases",[44,45],"atrial fibrillation","heart valve diseases","NOT_YET_RECRUITING","2024-11-20",{"date":49,"type":50},"2024-11-25","ACTUAL",{"date":52,"type":36},"2025-06",{"date":54,"type":36},"2026-08",{"name":5,"class":6}]