[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-septal-defects-atrial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-septal-defects-atrial":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100616034","study-on-the-safety-and-effectiveness-of-a-biodegradable-patent-foramen-ovale-occluder-system-100616034",false,"NCT07300358","Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System","BIOCLOSE-PFO Study：Evaluation of the Safety and Efficacy of a Biodegradable Patent Foramen Ovale Occluder System: A Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Study","BIOCLOSE-PFO","Inclusion Criteria:\n\n* Aged between 18 and 65 years.\n* Presence of a patent foramen ovale (PFO) confirmed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).\n* Presence of a moderate-to-large right-to-left shunt (RLS) at rest or during the Valsalva maneuver, as confirmed by agitated saline contrast echocardiography (also known as bubble study).\n* Clinically diagnosed with a PFO-associated ischemic stroke or transient ischemic attack (TIA).\n\nExclusion Criteria:\n\n* An alternative, clearly identified cause of ischemic stroke or TIA (other than PFO) is determined by the investigator.\n* Large territory cerebral infarction within 4 weeks prior to the planned procedure.\n* Atherosclerotic stenosis (\\>50%) of the carotid or vertebral arteries, as confirmed by CT angiography or vascular ultrasound per investigator assessment.\n* Presence of intracardiac thrombus or vegetation as confirmed by echocardiography.\n* Left ventricular ejection fraction (LVEF) \\\u003C 35%.\n* Atrial fibrillation or atrial flutter.\n* Left ventricular aneurysm or severe regional wall motion abnormality.\n* Significant valvular stenosis or regurgitation, or history of valvular replacement or repair surgery.\n* Pulmonary hypertension or a PFO constituting a special conduit (e.g., right-to-left shunt due to elevated right heart pressures).\n* Other confirmed causes of right-to-left shunt, such as atrial septal defect (ASD) or pulmonary arteriovenous fistula.\n* Complex PFO anatomy (e.g., multi-tunnel PFO) or PFO associated with an ASD requiring different closure strategy.\n* Thrombus, mass, or vegetation identified at the intended implant site or along the potential delivery pathway.\n* Acute myocardial infarction or unstable angina within 3 months prior to the procedure.\n* Previous implantation of an inferior vena cava filter, PFO closure device, or ASD closure device.\n* Any other condition deemed by the investigator to make the patient unsuitable for PFO device implantation.\n* Concomitant cardiac anomalies requiring surgical correction.\n* Uncontrolled systemic or local infection, or sepsis.\n* Active infection requiring concurrent antibiotic therapy (Patients with transient conditions may be enrolled after completing antibiotic therapy and a subsequent 14-day washout period).\n* Contraindication to antiplatelet or anticoagulant therapy (e.g., major bleeding within 3 months, known retinopathy, history of intracranial hemorrhage, or other significant intracranial pathology).\n* Known hypersensitivity or allergy to tantalum or nickel.\n* Pregnancy, lactation, or women of childbearing potential not using highly effective contraception.\n* Life expectancy less than 1 year due to malignancy or other comorbid disease.\n* Current participation in another investigational drug or device clinical study that has not yet completed its primary endpoint.","ALL","18 Years","65 Years",{"count":21,"type":22},258,"ESTIMATED","INTERVENTIONAL",[25],"NA","To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)",[28,29,30,31,32,33,34,35],"Cardiovascular Diseases","Cardiovascular Abnormality","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Atrial","Foramen Ovale, Patent","Stroke, Ischemic","Stroke (CVA) or TIA","NOT_YET_RECRUITING","2025-12-09",{"date":39,"type":40},"2025-12-23","ACTUAL",{"date":42,"type":22},"2025-12-30",{"date":44,"type":22},"2027-06-30",{"name":46,"class":47},"Shanghai Lingsi Medical Technology Co., Ltd.","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100602438","beta-blockers-for-prevention-of-supraventricular-arrhythmia-following-pfo-closure-100602438","NCT07123506","Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure","BRAVE PFO","Inclusion Criteria:\n\n1. Age 19 years or older\n2. Patients scheduled to undergo Patent Foramen Ovale closure using the Cocoon Patent Foramen Ovale Occluder\n3. Individuals who have provided informed consent for study participation\n\nExclusion Criteria:\n\n1. History of paroxysmal, persistent, or permanent atrial arrhythmia\n2. Atrial arrhythmia confirmed by a 14-day Holter ECG using the AT Patch before PFO closure\n3. Patients with uncontrolled asthma or chronic obstructive pulmonary disease (COPD)\n4. Patients with high-degree atrioventricular (AV) block\n5. History of heart failure, severe valvular disease, or left ventricular dysfunction (ejection fraction \\\u003C50%)\n6. Patients for whom initiating or discontinuing beta-blocker therapy is deemed impossible by the investigator\n7. Patients who, as assessed by the investigator, cannot be followed up for one year after enrollment\n8. Patients with hypersensitivity or contraindications to any proposed drug therapy or device component\n9. Patients with an expected life expectancy of less than one year\n10. Patients currently participating in another investigational drug or device study","20 Years",{"count":57,"type":22},350,[25],"\"The primary objective of the study is to evaluate whether the incidence of symptomatic or asymptomatic atrial fibrillation, atrial flutter, and atrial tachycardia within 30 days after percutaneous closure of idiopathic patent foramen ovale is reduced in the beta-blocker treatment group compared to the non-treatment group.\n\nThe secondary objective is to assess the safety and performance of the Cocoon Patent Foramen Ovale Occluder and collect real-world data on patient outcomes.\n\nPatients will be randomly assigned in a 1:1 ratio to either the beta-blocker treatment group or the non-treatment group. Randomization will be performed using a 1:1 allocation ratio with stratification based on (1) PFO device size and (2) sex, employing a block randomization method (mixed block sizes of 4 or 6). This process will be conducted independently through an interactive web response system.\n\nThe beta-blockers used in this study are extended-release beta-blockers, specifically bisoprolol or nebivolol. The choice between bisoprolol and nebivolol will be determined at the discretion of the investigators, with the initial dose set at the minimum dose for each drug (1.25 mg once daily). During the study period, adjustments to the beta-blocker dose, including maintenance or modification, will be made based on the investigators' clinical judgment, taking into account the patient's heart rate, blood pressure, and medication adherence. All reasons for dose adjustments will be documented in detail.\"",[61,62,63,32],"Atrial Fibrillation","Atrial Flutter","Tachycardia, Supraventricular","2025-08-07",{"date":66,"type":40},"2025-08-14",{"date":68,"type":22},"2025-09",{"date":70,"type":22},"2029-05-03",{"name":72,"class":47},"Yonsei University",1]