[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"left-atrial-appendage-occlusion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:left-atrial-appendage-occlusion":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,71,97,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100617023","pulsed-field-ablation-for-non-valvular-atrial-fibrillation-after-left-atrial-appendage-occlusion-100617023",false,"NCT07313228","Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion","Pulsed Field Ablation of Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion: A Prospective, Single-center, Single-arm Clinical Trial","PFA after LAAO","Inclusion Criteria:\n\n1. Aged 18-75 years;\n2. Documented symptomatic atrial fibrillation;\n3. Ineffective or intolerant to at least one class I or III antiarrhythmic drug;\n4. Able to fully understand the treatment protocol, voluntarily sign the informed consent form, and willing to undergo the required examinations, procedures, and follow-up.\n\nExclusion Criteria:\n\n1. Patients who have previously undergone left atrial surgery;\n2. Left atrial thrombus;\n3. Patients with pulmonary agenesis;\n4. Female patients of reproductive age who cannot use effective contraception within 12 months after enrollment;\n5. Left atrial anteroposterior diameter ≥ 55 mm;\n6. Left ventricular ejection fraction (LVEF) ≤ 40%;\n7. Patients who have previously undergone interatrial septal repair or removal of atrial myxoma;\n8. Patients with active implanted devices (e.g., pacemaker, ICD);\n9. Patients with NYHA heart failure class III-IV;\n10. Patients with a clear history of cerebrovascular disease (including cerebral hemorrhage, stroke, or TIA) within the past 6 months;\n11. Patients who have experienced cardiovascular events (e.g., acute myocardial infarction, coronary intervention or bypass surgery, valve replacement or repair, atrial or ventricular surgery) within the past 3 months;\n12. Patients with acute or severe systemic infections;\n13. Patients with severe liver or kidney disease, malignancy, or end-stage disease that may affect the treatment, assessment, or compliance of the trial (as judged by the investigator);\n14. Patients with significant bleeding tendency, hypercoagulable state, or severe hematologic disorders;\n15. Patients who have participated or are currently participating in another clinical trial within the past 12 months prior to enrollment;\n16. Patients who the investigator deems unsuitable for participation in this trial.","ALL","18 Years","75 Years",{"count":21,"type":22},70,"ESTIMATED","OBSERVATIONAL","This is a single-center, prospective, single-arm clinical trial designed to evaluate the safety and efficacy of pulsed field ablation (PFA) after left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). The trial will include patients who have undergone successful LAAO and have symptomatic AF that is refractory to or intolerant of class I or III antiarrhythmic drugs. The primary objective is to assess the effectiveness of PFA in preventing AF recurrence and its safety, including the occurrence of serious adverse events. Patients will be followed up for 12 months post-procedure to evaluate outcomes such as recurrence of AF, complications, and device-related issues.",[26,27,28],"Atrial Fibrillation","Left Atrial Appendage Occlusion","Pulsed Field Ablation",[26,30,31],"left atrial appendage occlusion","pulsed field ablation","NOT_YET_RECRUITING","2025-12-17",{"date":35,"type":36},"2025-12-31","ACTUAL",{"date":38,"type":22},"2025-12",{"date":40,"type":22},"2027-06",{"name":42,"class":43},"First Affiliated Hospital of Ningbo University","NETWORK",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100612748","left-atrial-appendage-occlusion-in-dialysis-patients-with-atrial-fibrillation-a-multicentre-pilot-study-100612748","NCT07257614","Left Atrial Appendage Occlusion in Dialysis Patients With Atrial Fibrillation: A Multicentre Pilot Study","LAAO-DAF","Inclusion Criteria:\n\n* Age \\>=18\n* End stage renal failure on peritoneal dialysis or haemodialysis\n* documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;\n* CHADS2-VASc \\>=2\n* The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations;\n* Able to consent\n\nExclusion Criteria:\n\n* Patients who require long-term anticoagulation for a condition other than AF, e.g. pulmonary embolism, deep vein thrombosis, anti-phospholipid syndrome\n* Mechanical valve replacement\n* Active infection with bacteraemia;\n* Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy\n* Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and\u002For contrast;\n* Left atrial appendage is obliterated and surgical ligated;\n* Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, etc.);\n* Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;\n* New York Heart Association Class IV;\n* Life expectancy is less than 1 year;\n* Current participation in another investigational drug or device study.\n* Echocardiogram exclusion:\n\n  i. Moderate mitral stenosis or above ii. LVEF \\\u003C30% iii. Intracardiac thrombus iv. Presence of a cardiac tumour. v. Existing circumferential pericardial effusion \\>5 mm; vi. Presence of a high-risk Patent Foramen Ovale (PFO), defined as an atrial septal aneurysm (excursion \\>15 mm or length \\>15 mm) or large shunt (early, within 3 beats and\u002For substantial passage of 20 bubbles)",{"count":52,"type":22},40,"1 Year","Objectives: This pilot study aims to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) in dialysis patients and atrial fibrillation (AF) to establish a novel stroke prevention strategy and determine an optimal post-occlusion antithrombotic regime. Page 3 of 50 Hypothesis: The study tests the hypotheses that LAAO is safe for dialysis patients, that a single antiplatelet regimen postprocedure is safe, and that LAAO effectively reduces the composite endpoint of stroke\u002Ftransient ischemic attack and major bleeding compared to standard care. Instruments: The study employs a multicenter, single-arm prospective registry design. Eligible participants, aged ≥18 with documented AF and ESRF on peritoneal dialysis (PD) or hemodialysis (HD), will undergo LAAO using the Watchman Flx PRO device. Propensity score matched historical cohort from dialysis registry will be identified for comparison.\n\nMain Outcome Measures: The primary endpoint is the composite of stroke\u002Ftransient ischemic attack\u002Fsystemic embolism and non-procedural-related major bleeding at one year. Secondary endpoints include individual rates of these events, procedural safety and device occlusion effectiveness. Data Analysis and Expected Results: Statistical analysis will involve descriptive statistics, chi-squared tests, and propensity score matching. A p-value of \\\u003C0.05 will be deemed significant. The pilot study anticipates a low peri-procedural complication rate (≤5%) and confirms LAAO's efficacy in stroke and major bleeding reduction in Chinese PD and HD patients compared to standard care. This data will inform the design of a larger randomized controlled trial aimed at validating LAAO as a safe alternative for AF management in dialysis populations.",[56,57,26,58,59,27],"Dialysis","Chronic Kidney Disease (Stages 3b-5)","End Stage Kidney Failure","Stroke Prevention in Patients With Atrial Fibrillation","2025-12-02",{"date":62,"type":36},"2025-12-04",{"date":64,"type":22},"2026-01-05",{"date":66,"type":22},"2028-07-05",{"name":68,"class":69},"Prince of Wales Hospital, Shatin, Hong Kong","OTHER",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":70},"100590569","rct-of-minimalist-vs-standard-procedure-for-laac-in-nvaf-patients-100590569","NCT06969118","RCT of Minimalist vs Standard Procedure for LAAC in NVAF Patients","A Multi-center, Randomized, Controlled Study Comparing Minimalist Procedure With Standard Procedure for Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation","Inclusion Criteria:\n\n1. Age 18 - 85 years old, all genders;\n2. Subjects who can understand the purpose of the trial, participate voluntarily and sign the informed consent form, and are willing to complete the follow-up according to the protocol requirements;\n3. Indications for left atrial appendage closure: non-valvular atrial fibrillation patients with CHA2DS2-VAS2 score ≥2 and HAS-BLED score ≥3, or who are unable or unwilling to receive long-term oral anticoagulants;\n4. Life expectancy ≥1 year;\n\nExclusion Criteria:\n\n1. Preoperative TEE\u002Fheart CT\u002Fintracardiac ultrasound suggested thrombus in the left atrial appendage\u002Fleft atrium;\n2. Patients with severe renal insufficiency (creatinine ≥200 μmol\u002FL, creatinine clearance \\\u003C30 ml\u002Fmin);\n3. Liver disease patients with coagulation abnormalities and clinically relevant bleeding risks, including liver cirrhosis patients reaching Child Pugh stages B and C;\n4. Severely decreased platelet count at baseline: PLT ≤50\\*10\\^9\u002FL;\n5. Patients with severe preoperative cardiac insufficiency (LVEF \\\u003C35%; clinical manifestations are uncontrolled class IV heart failure);\n6. Combined with other severe cardiac valvular diseases or other structural abnormalities that require surgical treatment on an elective day; or severe coronary heart disease that requires intervention within a fixed period;\n7. Patients who have lesions or conditions with a significant risk of major bleeding, such as current or recent gastrointestinal ulcers, malignant tumors with a high risk of bleeding, recent brain or spinal injuries, recent brain, spinal or ophthalmic procedure, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular malformations;\n8. Patients with concurrent diseases (other than atrial fibrillation) that require anticoagulant therapy (such as after mechanical valve replacement, and spontaneous or recurrent venous thromboembolism);\n9. Patients who are in clinical trials of other drugs or medical devices and have not completed it yet;\n10. Patients who are considered ineligible to participate in the clinical trial by the investigator.","85 Years",{"count":80,"type":22},200,"INTERVENTIONAL",[83],"NA","Percutaneous left atrial appendage closure (LAAC) is an effective strategy for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Standard procedure requires general anesthesia, transesophageal echocardiography (TEE) guidance. With the experience accumulation, LAAC can be successfully completed in many centers under local anesthesia, the guidance of X-ray and transthoracic echocardiography (TTE), also known as minimalist procedure. Our center was one of the earliest to carry out minimalist procedure worldwide. At present, expert consensus suggests that minimalist procedure is feasible in experienced centers, but the relevant evidence is insufficient. Some single-arm studies have shown that minimalist procedure is safe and effective. However, there is currently a lack of direct evidence to compare the strengths and weaknesses of these two LAAC procedures. The goal of the study was to compare the effectiveness and safety of minimalist procedure and standard procedure for LAAC in patients with NVAF.",[26,27,86,87],"General Anesthesia","Local Anesthesia","2025-05-06",{"date":90,"type":36},"2025-05-13",{"date":92,"type":22},"2025-06-01",{"date":94,"type":22},"2027-06-01",{"name":96,"class":69},"Shanghai Zhongshan Hospital",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":53,"studyType":23,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":70},"100570101","combined-leadless-pacemaker-and-left-atrial-appendage-occlusion-registry-100570101","NCT06702865","Combined Leadless Pacemaker and Left Atrial Appendage Occlusion Registry","Inclusion Criteria:\n\n1. Age \\> 18-year-old\n2. Patients satisfying guideline Class I or Class II indication for pacemaker 6,7\n3. Patients with atrial fibrillation\n4. Patient deemed indicated for left atrial appendage occlusion after a shared decision making between physician and patient\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Expected life expectancy \\\u003C1 year\n3. Patients with known mitral stenosis\n4. LVEF \\\u003C30%\n5. Severe mitral regurgitation",{"count":104,"type":22},47,"Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in selected patients. Implantation is performed with a large caliber delivery catheter. Care must be taken in introducing the delivery catheter into the patient's venous system. Implantation in patients with small body habitus demands extra caution to avoid vascular injury and cardiac perforation. Negotiating the large caliber delivery catheter into the desired implant position may also be more difficult in small right ventricles. In a previous report of Micra leadless pacemakers, it was found that low BMI was associated with poor efficacy and safety.\n\nThe Aveir leadless pacemaker is a new leadless pacemaker that has obtained FDA approval and is commercially available in Hong Kong. It features a screw-in fixation mechanism, in contrast to the passive fixation of Micra. Most of its efficacy and safety data comes from a Western population. It would be important to study its efficacy and safety in an Asian population, who tend to have smaller body builds, hence more prone to complications.\n\nIn recent papers regarding the Micra leadless pacemaker, it was found that tricuspid regurgitation (TR) could be a result, especially if the implant was too close to the tricuspid valve. Given the almost 50% longer device dimension of the Aveir VR compared with the Micra leadless pacemaker (38mm vs 26mm), it is expected that the device mechanical interaction with tricuspid valve dysfunction can be more common. In the smaller hearts of an Asian population, it would be important to study the TR progression after device implantation.\n\nAbout half of the patients implanted with leadless pacemakers were having concomitant atrial fibrillation and thus were at risk for thromboembolic events. Left atrial appendage occlusion was an effective procedure for stroke prevention in patients with atrial fibrillation. Because one patient often has indication for both LAAO and leadless pacemaker, combining them into the same procedure is appealing. The combined procedure can be performed with one single access. The imaging used to guide LAAO implantation can also be used to guide leadless pacemaker implantation to improve the procedure safety.\n\nThis study is a prospective observational study. Patients indicated for combined leadless pacemaker and left atrial appendage occlusion will be enrolled. Patients would fulfill guideline Class I and Class II indication for leadless pacemaker. The decision for left atrial appendage occlusion will be a shared decision-making process between the physician and patient. The consideration is usually based on patient's bleeding risk, tolerability for oral anticoagulation and patient preference.",[107,27],"Leadless Pacemaker","2024-11-20",{"date":110,"type":36},"2024-11-25",{"date":112,"type":22},"2024-11",{"date":114,"type":22},"2027-12",{"name":116,"class":69},"Chinese University of Hong Kong",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":81,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":70},"100520772","lambre-versus-amplatzer-amulet-left-atrial-appendage-occluder-for-stroke-prophylaxis-100520772","NCT06060912","LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs","LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial","AMPIRI","Inclusion Criteria:\n\n* Age ≥ 18 years and able to give consent\n* Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation\u002F atrial flutter (AF) at high risk of stroke or systemic embolism defined by CHA2DS2-VASc score ≥ 2 (male) or ≥ 3 (female)\n* Patient not eligible for long-term oral anticoagulation therapy\n* Deemed suitable for percutaneous LAAO\n* Able to comply with the required medication regimen after LAAO device implantation\n* Written informed consent\n* LAA anatomy can accommodate either a LAmbre or AMPLATZER Amulet LAAO device, as per manufacturer's instruction for use (IFU) (the anatomy and sizing must be appropriate for both devices in order to be enrolled in the trial)\n* For women of childbearing potential, negative pregnancy test and agree to use reliable method of birth control during the study\n\nExclusion Criteria:\n\n1. Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve)\n2. LAA is obliterated or surgically ligated\n3. Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen\n4. Prior atrial septal defect (ASD) repair or implantation of ASD closure device\n5. Active endocarditis or other infection producing bacteremia\n6. Significant symptomatic carotid artery disease\n7. Participation in a concurrent clinical trial, which may confound the results of this trial\n8. Patient cannot adhere to or complete the trial protocol for any reason\n\n   Or any of the following echocardiographic exclusion criteria:\n9. Intracardiac thrombus\n10. Intracardiac tumor\n11. Existing, clinically relevant circumferential pericardial effusion\n12. Significant mitral valve stenosis","100 Years",{"count":127,"type":22},226,[83],"The objective of this trial is to compare two different commercially available left atrial appendage occlusion (LAAO) devices in patients with non-valvular Atrial fibrillation\u002F atrial flutter (AF) at increased risk for stroke with regard to safety and efficacy.\n\nThe investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is peri-device leak (PDL) size 3 months after LAAO, as assessed with transesophageal echocardiography (TOE) in patients with non-valvular AF.",[27],[27,132,133],"Non-pharmacological anticoagulation therapy","Stroke prophylaxis","RECRUITING","2024-01-07",{"date":137,"type":36},"2024-01-09",{"date":139,"type":36},"2023-12-05",{"date":141,"type":22},"2027-10-15",{"name":143,"class":69},"Deutsches Herzzentrum Muenchen"]