[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patent-foramen-ovale\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patent-foramen-ovale":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,49,76,107,135,164,189,222,248,269,294,324,344,363,387,411,429,449,470,491],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100054020","evaluating-percutaneous-repair-of-the-atrial-septum-with-a-novel-pfo-occluder-the-protea-pfo-ous-study-100054020",false,"NCT07698951","Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study","PROTEA-PFO OUS","Inclusion Criteria:\n\n1. Patient must be ≥ 18 and ≤ 65 years of age\n2. Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and\u002For during Valsalva release.\n3. Ischemic stroke, defined as acute focal neurological deficit, presumed to be due to focal ischemia and confirmed by MRI or CT to have a neuroanatomically relevant cerebral infarct.\n4. Modified Rankin score (mRS) ≤ 3.\n5. Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee.\n6. Patient is willing and capable of providing informed consent.\n7. Prior to index procedure (7-day window), persons of childbearing potential must have a negative pregnancy test.\n\nExclusion Criteria:\n\n1. Other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding \\>4 mm into the lumen), large artery atherosclerotic disease proximal to the territory of the index stroke, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection, presence of left atrial appendage thrombus.\n2. Other arteriopathy of the intracranial or extracranial vessels with \\>50% stenosis proximal to the territory of the index stroke.\n3. Intracardiac thrombus or tumor.\n4. Myocardial Infarction (MI) or unstable angina within the previous 180 days.\n5. Life expectancy \\\u003C 2 years.\n6. Left ventricular aneurysm or akinesis.\n7. Moderate to severe mitral valve stenosis or severe mitral regurgitation.\n8. Aortic valve stenosis (mean gradient \\>20 mmHg) or severe regurgitation.\n9. Active endocarditis or other infection that may preclude implantation of the investigational device.\n10. Any valve vegetation or Lambl's excrescence of any left-sided valve.\n11. Left ventricular dilated cardiomyopathy with LVEF \\\u003C35%.\n12. Another source of right-to-left shunts identified at baseline, including an atrial septal defect and\u002For fenestrated septum and pulmonary arteriovenous malformation.\n13. History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker, or AICD.\n14. Severe renal failure ( Stage 4 CKD, eGFR \\\u003C30) or patient requiring dialysis.\n15. Severe liver disease (e.g., documented cirrhosis or active hepatitis).\n16. Severe lung insufficiency (e.g., need for supplemental oxygen or chronic steroid medications).\n17. Uncontrolled hypertension, defined as sustained elevated blood pressure \\>140\u002F90 mm Hg.\n18. Severe pulmonary artery hypertension, defined as pulmonary systolic pressure of \\>50mmHg.\n19. Uncontrolled hyperglycemia, defined as HbA1c value \\>8% (IFCC: \\>64 mmol\u002Fmol).\n20. Increased bleeding risk such as severe liver failure, active peptic ulcer, proliferative diabetic retinopathy, history of severe bleeding (e.g.: gastrointestinal bleeding, macroscopic hematuria, intraocular bleeding, intracranial or cerebral hemorrhage), or other history of bleeding or coagulopathy.\n21. Known hypercoagulable state that would require full anticoagulation. Minimum testing to include lupus anticoagulant, anticardiolipin antibodies, beta-2-glycoprotein, homocysteine.\n22. Subjects contraindicated for aspirin or clopidogrel.\n23. Subjects not able to discontinue anticoagulation for indications other than then index stroke.\n24. Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation or require premature discontinuation of antiplatelet regime post-implantation, as well as any severe concurrent illness that would limit life expectancy (e.g., malignancies).\n25. Currently an active subject in an investigational drug or device study that could confound the results of this study.\n26. Any significant valve dysfunction that contraindicates PFO closure or increased pulmonary vascular resistance\u002Fsevere pulmonary hypertension.\n27. Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).\n28. Any prior percutaneous cardiovascular intervention for AF ablation.\n29. Known nickel allergy that, in the opinion of the investigator, poses a safety risk with regards to participation in the trial.","ALL","18 Years","65 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a stroke that may be related to this heart opening. The main question it aims to answer is:\n\n• Is the P3 Occluder System safe and effective for closing a PFO in patients who have had a stroke that could be related to a PFO.\n\nParticipants will:\n\n* Undergo the procedure to implant the P3 Occluder System, if deemed appropriate.\n* Visit their doctor at 1 month, 3 months, 6 months, and 1 year after the procedure for follow up exams.\n* Answer a phone call from study staff at 2 years and 3 years after the procedure to answer a survey.",[27,28,29,30,31],"PFO","PFO - Patent Foramen Ovale","Cryptogenic Stroke","Patent Foramen Ovale","PFO-associated Stroke",[30,27,29,33,34,35],"PFO Occluder","Transcatheter","PFO-associated stroke","RECRUITING","2026-07-07",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2026-06-17",{"date":44,"type":21},"2029-12",{"name":46,"class":47},"Recross Cardio, Inc.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":20},"100525325","ceraflex-pfo-closure-system-pmcf-study-100525325","NCT06120270","CeraFlex PFO Closure System PMCF Study","CeraFlex PFO Closure System Post-Market Clinical Follow-up Study: A Multi-center, Prospective, Observational, Post-market Study","Inclusion Criteria:\n\n1. Patient with indication(s) for PFO Occluder Closure in the Instruction For Use (IFU):\n\n   1. Confirmed PFO by medical examinations;\n   2. Associated with recurrent migraine\u002Fheadache or TIA or cryptogenic stroke.\n2. Patient characteristics consistent with the corresponding IFU \\& Device Size Selection:\n\n   1. Measure the distance from the defect to the aorta root;\n   2. Measure the distance from the defect to the superior vena cava (SVC) rim; select a device with the radius of the right disc that will not exceed the lesser of these two distances.\n3. Patients who are willing to comply with all study procedures and be available for the duration of the study.\n4. Patients or legally authorized representative(s) who are willing and capable of providing informed consent.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years or Age \\>85 years.\n2. Patient with a history of ongoing Atrial Fibrillation (AF).\n3. Patient with malignancy or other illness where life expectancy is less than 1 year.\n4. Patient not covered by a social security scheme.\n5. Patients who are participating in an investigational drug or device study currently.\n6. Women of childbearing potential who are, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion).\n7. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.\n8. Any contraindication mentioned in the corresponding IFU：\n\n   1. Patients known to have intracardiac thrombi, especially left atrial or left atrial appendage thrombi, demonstrated by echocardiography. Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy unless another anti-platelet agent can be administered for 6 months.\n   2. Anatomy in which the CeraFlexTM PFO device of the required size would interfere with intra-cardiac structure or intra-vascular structure, such as a pulmonary vein, or aorta root.\n   3. Patients whose heart or vein size is too small to allow TEE probing or catheterization.\n   4. Patients who are in the condition, e.g. active infection, which would cause them to be poor candidates for cardiac catheterization.\n   5. Patients known to have sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.\n   6. Patients whose heart does not have enough tissue to secure the device.\n   7. Patients with hypercoagulation disease.\n   8. Any patient for whom the radius of the device is greater than the distance from the patent foramen ovale to the aortic root or superior vena cava.\n\n      * No contraindications specified in the SteerEase introducer IFU.","85 Years",{"count":58,"type":21},180,"OBSERVATIONAL","The purpose of this study is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.",[30],[63,30,27,64,65,66],"Lifetech","CeraFlex","CeraFlex PFO","CeraFlex PFO Closure System","2026-06-08",{"date":69,"type":40},"2026-06-10",{"date":71,"type":40},"2023-11-03",{"date":73,"type":21},"2028-12",{"name":75,"class":47},"Lifetech Scientific (Shenzhen) Co., Ltd.",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":48},"100638428","phase-3-migraine-headaches-elimination-with-patent-foramen-ovale-directed-therapy-100638428","NCT07629635","Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy","Cessation of Migraine Headaches With Patent Foramen Ovale-Directed Therapy (COMFORT - PFO): An Investigator-Initiated Study","COMFORT-PFO","Patient Inclusion Criteria:\n\n* Age: ≥18 and \\\u003C55 at time of screening\n* Migraine headache with aura, or migraine headache without aura, fulfilling conditions of the Neurology Screening Tool (meeting ICHD-3 criteria)\n* Diagnosis of migraine for ≥ 1 year; onset of migraine symptoms \\\u003C 40 years of age\n* By history, an average headache burden of greater than one migraine headache day per week:\n* without current preventative therapy, OR\n* despite preventative therapy, OR\n* with reason to come off effective therapy (e.g. cost, aversion to injections, side effects)\n* If patient is taking preventive migraine medications, dose must be stable for at least 3 months prior to the screening visit. Patient agrees to continue preventive medication at the current dosage throughout the duration of the Baseline and On-treatment monitoring periods (Study Weeks 1 - 17).\n* Female patients capable of becoming pregnant agree to use two forms of birth control or abstinence during their participation in the study.\n\nPatient Exclusion Criteria:\n\nExclusions due to underlying patient medical issues:\n\n* Headache disorder other than migraine with aura, or migraine without aura\n* Patient has history of stroke, TIA, or intracranial hemorrhage.\n* Patient has a history of thrombocytopenia within one year, or platelet count \\\u003C100,000\u002Fmm3 identified during the screening laboratory evaluation.\n* Patient has severe hepatic impairment with reduced synthetic function as documented by prolongation of PT\u002FPTT, or with total bilirubin \\>3.0 mg\u002FdL identified during the screening laboratory evaluation.\n* Patient has previously implanted pacemaker, IVC filter, PFO closure device, ASD closure device, or left atrial appendage closure device or any cardiac history which, in the investigator's opinion, would preclude them from study participation.\n* Patient has documented right-to-left shunt source in addition to PFO such as atrial septal defect or pulmonary arteriovenous malformation.\n* Patient has a history of clinically significant bleeding within 6 months of the screening visit, any active bleeding, or active peptic ulcer disease.\n* Patient has an uncontrolled arrhythmia, or if on therapy, has evidence of arrhythmia control failure within the past 90 days (e.g., supraventricular tachycardia or atrial fibrillation while under rhythm control).\n* Patient has elevated PVR which in the opinion of the implanting physician precludes safe PFO closure.\n* Patient has active infection at the time of screening that cannot be treated.\n* Patient is planning surgery during the study timeframe.\n* A female patient is pregnant or is planning pregnancy during the anticipated duration of the study. Urine or blood pregnancy screening will be performed as part of the screening laboratory evaluation.\n* Patient has documented nickel allergy\u002Fsensitivity\n* Patient has a documented history of non-compliance with medical care, which would preclude them, in the opinion of the study team\n\nExclusion Due to Medication Restrictions:\n\n* Patient has known hypersensitivity or contraindication to thienopyridines\n* Patient has another medical condition requiring chronic antithrombotic therapy with antiplatelet, oral anticoagulant or injectable agents\n* Patient has need for daily use of NSAIDs other than for treatment of migraines","55 Years",{"count":86,"type":21},32,[88],"PHASE3","Migraine is a common and often disabling condition, but its exact causes are not fully understood. Some people with migraines have a small opening in the heart wall called a patent foramen ovale (PFO). In some of these patients, closing this opening or taking a medication that inhibits blood platelets (prasugrel) has been shown to reduce migraines. However, not everyone benefits, and it is unclear why. This study is being done to better understand whether closing a PFO can provide lasting migraine relief - especially in patients whose migraines improve with prasugrel.\n\nThe goal of this study is to find out whether, in patients whose migraines improve while taking prasugrel, closing the PFO along with 24 weeks of prasugrel leads to better long-term migraine relief after stopping the medication, than by taking prasugrel for 24 weeks alone.\n\nParticipants will track their migraines daily using an electronic diary, then take prasugrel and compare their migraines while on the medication. Only patients whose migraines improve on this medication will continue in the study. Eligible participants will be randomly assigned (like flipping a coin) to one of two groups: 1) Medication-only group: Continue prasugrel for 24 weeks. 2) Procedure group: Undergo a minimally invasive procedure to close the PFO and continue prasugrel for 24 weeks. After treatment, the medication will be stopped in both groups, and participants will again track their migraines for about 8 weeks.\n\nThe main question is: Do patients who have PFO closure continue to have fewer migraines after stopping prasugrel compared with those who did not have the procedure?",[91,30],"Migraine Disease",[93,30,94,82,95],"Migraine Headaches","Thienopyridine","Prasugrel","NOT_YET_RECRUITING","2026-06-01",{"date":99,"type":40},"2026-06-05",{"date":101,"type":21},"2026-09-01",{"date":103,"type":21},"2028-03",{"name":105,"class":106},"Columbia University","OTHER",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":115,"studyType":59,"phases":4,"briefSummary":116,"conditions":117,"keywords":123,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100635406","hummingbird-ice-study-100635406","NCT07552272","Hummingbird ICE Study","Inclusion Criteria:\n\n* 18 years of age\n* Willing to provide written, dated and signed, informed consent\n* Undergoing percutaneous cardiac intervention procedures in with VeriSight Pro is used\n\nExclusion Criteria:\n\n* Contraindicated for ICE catheter placement or considerations that make placement of VeriSight not technically feasible\n* Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease",{"count":114,"type":21},1000,"2 Days","The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of the VeriSight Pro imaging platform.",[118,119,120,121,30,122],"ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION","Atrial Fibrillation (AF)","Valve Disease, Heart","Atrial Septal Defect","Tricuspid Valve Disease",[124,125],"Intracardiac Echocardiography (ICE)","VeriSight","2026-05-18",{"date":128,"type":40},"2026-05-22",{"date":130,"type":21},"2026-07",{"date":132,"type":21},"2031-07",{"name":134,"class":47},"Philips Clinical & Medical Affairs Global",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":4},"100622197","comparing-two-pfo-closure-devices-in-adults-with-previous-stroke-or-tia-100622197","NCT07380490","Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA","Randomised Controlled Trial Comparing the Safety and EfficAcy of the Cocoon PFO Occluder Versus Amplatzer PFO ClosurE Device for Percutaneous Closure of Patent Foramen Ovale in Patients With a History of Stroke or Transient Ischemic Attack A Non-Profit, Single-blind, Investigator Driven Trial","SAFE-PFO","Inclusion Criteria:\n\n* Patients with \\>18 years of age and \\\u003C65 years of age, regardless of gender\n* Patients with normal or aneurysm type PFO confirmed by imaging examination \\[Transthoracic Echocardiography (TTE)\u002F Transesophageal Echocardiography (TOE) or Intracardiac Echocardiography\\], and who exhibit spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.\n* Patients with history of cryptogenic embolic stroke or transient ischemic attack in the previous 12 months \\[stroke is defined as acute focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT findings of a new, neuroanatomically relevant, cerebral infarct. Transient Ischemic Attack is defined as acute focal neurological deficit (defined as focal motor deficit, aphasia, difficulty walking, hemisensory deficit, amaurosis fugax, blindness, or focal visual deficit) presumed due to focal ischemia, lasting between 5 minutes and 24 hours, that is not associated with MR or CT findings of a new cerebral infarct\\]. The diagnosis of cryptogenic embolic stroke or TIA has to be confirmed by a neurologist.\n* The size of PFO must be amenable to selection of a Cocoon PFO Occluder or Amplatzer PFO closure device.\n* Patients are informed of the nature of the trial and agree to all requirements for participation in the trial, signed the informed consent form, and agreed to complete the follow-up and follow-up examination\n\nExclusion Criteria:\n\n* Patients who have definite causes of stroke or transient ischemic attack unrelated to the PFO\n* RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt\n* Patients with atrial fibrillation\u002Fatrial flutter (chronic or intermittent) Intracardiac thrombus or tumor\n* Patients with mitral or aortic valve stenosis or severe regurgitation\n* Mitral or aortic valve vegetation or prosthesis\n* Active endocarditis or other untreated infectious diseases\n* Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy\n* Left ventricular ejection fraction (LVEF) \\\u003C35%\n* Left ventricular aneurysm or akinesis Myocardial infarction or unstable angina pectoris within 12 months\n* Previous intracardiac surgery or percutaneous PFO-closure\n* Atherosclerosis or arteriopathy of intra- or extracranial vessels with \\>50% diameter stenosis in the artery supplying the infarcted territory.\n* Patients with non-embolic cryptogenic stroke (for example lacunar stroke) or with other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding \\>4 mm into the lumen), large artery atherosclerotic disease, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection\n* Glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73 m2 or with any history of renal dialysis or renal transplantation\n* Severe liver function impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value）\n* Severe pulmonary disease including pulmonary hypertension (clinical diagnosis)\n* Uncontrollable hypertension or diabetes mellitus\n* Contraindications to anticoagulants or antiplatelet drugs, either before or after the PFO closure procedure\n* Active or planned (within 12 months) pregnancy, or lactating female patients\n* Patients with hypercoagulable states\n* Patients diagnosed with a neurological disease that causes progressive neurological dysfunction\n* Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months\n* Anatomy in which the device would interfere with intracardiac or vascular structures\n* Psychiatric conditions that may interfere with medical compliance and compliance with follow-up\n* Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet\n* Patient with any medical condition that would make him\u002Fher inappropriate for treatment as per the current IFU of respective devices or in the opinion of the Investigator\n* Inability to obtain Informed Consent from patient or legally authorized representatives\n* Stroke with poor outcome at time of enrollment (Modified Rankin score \\>3)\n* Subjects who will not be available for follow up for the duration of the trial",{"count":144,"type":21},1260,[24],"This study is a prospective, multicenter, randomized, controlled, single-blind, investigator-driven, non-profit clinical trial designed to compare the safety and efficacy of the Cocoon PFO Occluder with the Amplatzer PFO Occluder family in patients requiring percutaneous closure of a patent foramen ovale (PFO). Eligible participants are adults with a history of cryptogenic embolic stroke or neurologically confirmed transient ischemic attack (TIA) within the previous 12 months and a PFO suitable for transcatheter closure.\n\nA total of up to 1260 subjects will be enrolled across multiple European centers. Participants will be randomly assigned in a 3:1 ratio to receive either the Cocoon PFO Occluder (experimental group) or an Amplatzer PFO closure device (control group). The procedure will be performed as soon as possible after randomization, preferably within 14 days and no later than 45 days.\n\nThe primary endpoint is a non-inferiority comparison of a composite outcome at 12 months, including recurrent ischemic stroke, TIA, or all-cause death. Secondary endpoints include PFO closure rate at 6 months, assessed by echocardiographic imaging, and other measures of safety, device performance, and clinical outcomes.\n\nThe study is conducted in a single-blind fashion: patients will not be informed of the device they receive unless they explicitly request this information. Any patient who chooses to be unblinded will continue to participate without affecting eligibility or follow-up, and the date of unblinding will be documented to allow appropriate sensitivity analyses.\n\nThis trial aims to provide robust comparative evidence on the clinical performance of the Cocoon PFO Occluder relative to the Amplatzer PFO Occluder to guide optimal device selection in patients with cryptogenic stroke or TIA associated with PFO.",[30,148,149],"Stroke","Transient Ischemic Attack (TIA)",[151,152,153,30,29,154],"PFO Closure","Cocoon PFO Occluder","Amplatzer PFO Occluder","Transient Ischemic Attack","2026-03-23",{"date":157,"type":40},"2026-03-24",{"date":159,"type":21},"2026-04",{"date":161,"type":21},"2028-04",{"name":163,"class":47},"Giuseppe Tarantini",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100508997","medical-treatment-with-or-without-transcatheter-patent-foramen-ovale-closure-100508997","NCT05907694","Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure","Medical Treatment With or Without Transcatheter Patent Foramen Ovale CloSure for Older Patients With CrypTogenic StrOke and Patent Foramen Ovale. The STOP Trial","STOP","Inclusion Criteria:\n\n* Cryptogenic stroke\n* Age \\>60 years\n* Right-to-left shunt as evaluated by echocardiography (TEE).\n\nExclusion Criteria:\n\n-≤60 year-old\n\n* Lacunar (small vessel) stroke.\n* Permanent or paroxysmal atrial fibrillation\u002Fflutter (clinically apparent or detected by continuous ECG monitoring).\n* Need for chronic anticoagulation therapy.\n* Any contraindication for antiplatelet therapy (aspirin, clopidogrel, ticagrelor).\n* Presence of extracranial or intracranial atherosclerosis causing ≥50% luminal --stenosis in arteries supplying the area of ischemia.\n* Presence of complex atheroma plaques at the ascending aorta-aortic arch (≥4-mm-thick, ulcerated or containing mobile thrombi) as evaluated by TEE.\n* Presence of intracardiac thrombus as evaluated by TEE.\n* Uncontrolled hypertension (systemic pressure values \\>160\u002F90 mmHg despite optimal medical treatment).\n* History of myocardial infarction or coronary intervention. (percutaneous coronary intervention, coronary artery bypass graft).\n* History of prior valve surgery or transcatheter valve repair.\n* Presence of deep venous thrombosis at the time of index stroke as evaluated by Doppler ultrasonography.\n* Left ventricular ejection fraction \\\u003C50% as evaluated by TTE.\n* Significant (moderate or severe) valvular disease as evaluated by echocardiography.\n* History of congestive heart failure.\n* Severe chronic kidney dysfunction defined an estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002Fm2 or need for dialysis.\n* Isolated ASD or ASD associated with PFO but with a hemodynamically significant left-to-right shunt requiring closure.\n* Other specific cause of stroke identified (eg, arteritis, dissection, migraine\u002Fvasospasm, and drug abuse).\n* Prior surgical or endovascular treatments of PFO or ASD.\n* Rheumatic heart disease.\n* Left atrial enlargement defined as a left atrial diameter \\>41 mm in men and ≥39 mm in women.\n* Presence of high burden of premature atrial contractions (\\>500 per 24 hrs) as evaluated by continuous ECG monitoring.\n* Follow-up impossible or expected poor compliance.\n* Active cancer.\n* Presence of an inferior vena cava filter.\n* Severe pulmonary artery hypertension (systolic pulmonary pressure \\>60 mmHg).\n* Functional dependency as measured by a modified Rankin Scale score \\>3 (unable to attend to own bodily needs without assistance and unable to walk unassisted).\n* Any medical condition determining a life expectancy \\\u003C2 years.\n* Participation in another randomized study.\n* Failure to provide signed informed consent.",{"count":173,"type":21},714,[24],"Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.",[30,29,177,178,179],"Older Patients","Medical Treatment","Recurrent Stroke",{"date":181,"type":40},"2026-03-27",{"date":183,"type":40},"2024-06-18",{"date":185,"type":21},"2037-10-01",{"name":187,"class":106},"Josep Rodes-Cabau",2,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":197,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100469065","phase-3-pfo-closure-oral-anticoagulants-or-antiplatelet-therapy-after-pfo-associated-stroke-in-patients-aged-60-to-80-years-100469065","NCT05387954","PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years","Transcatheter Patent Foramen Ovale (PFO) Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Between 60 and 80 Years Old : a Randomised Controlled Trial.","CLOSE-2","Inclusion Criteria:\n\n* Man or woman aged 60 to 80 years.\n* Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless of symptom duration.\n* Absence of a more probable cause of stroke than PFO after a standardized etiological work-up (see addenda).\n* Presence of a PFO with at least 1 of the 2 following characteristics:\n\n  * PFO with large shunt (\\> 20 microbubbles) appearing in the left atrium during at least one of the 3 cardiac cycles after complete opacification of the right atrium, detected either spontaneously or during provocative manoeuvers, on contrast transthoracic (TTE) or transoesophageal (TOE) echocardiography. The diagnosis of PFO by contrast TEE must be confirmed by contrast TOE showing a right-to-left passage of the contrast material across the PFO.\n  * PFO associated with an ASA on transoesophageal echocardiography: excursion \\>10 mm\n* Affiliation to a French Health Insurance system. Informed consent.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C 4 years.\n* Contraindication to both experimental treatments (PFO closure, oral anticoagulant therapy) or to the reference treatment (antiplatelet therapy) (see paragraph 20.5).\n* Indication to long-term anticoagulant therapy.\n* mRS \\> 3.\n* Presence of other medical conditions that would lead to inability to complete the study or interfere with the assessment of outcomes.\n* Previous surgical or transcatheter treatment of PFO or ASA. Expected impossible follow-up or poor compliance.\n* PFO associated with an atrial septal defect (ASD) requiring closure (significant shunt with impact on the right cavities, elevation of pulmonary pressures or QP\u002FQS\\>2)\n* Patient unable to understand the informed consent form. Patient under tutorship, curatorship, or legal protection.","60 Years","80 Years",{"count":200,"type":21},792,[88],"To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (\\> 20 microbubbles) or a PFO associated with an ASA (\\> 10 mm), and an otherwise unexplained ischemic stroke.",[204,30],"Cryptogenic Ischemic Stroke",[206,207,208,209,210,211,212,213],"Ischemic stroke","Cryptogenic stroke","Patent foramen ovale","Atrial septal aneurysm","Transcatheter PFO closure","Oral anticoagulants","Antiplatelet therapy","Randomized clinical tria",{"date":157,"type":40},{"date":216,"type":40},"2023-07-07",{"date":218,"type":21},"2031-07-07",{"name":220,"class":106},"Assistance Publique - Hôpitaux de Paris",42,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":230,"sex":16,"minAge":17,"maxAge":197,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":238,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":48},"100399003","discontinuation-of-antithrombotic-treatment-following-patent-foramen-ovale-closure-in-young-patients-with-cryptogenic-stroke-100399003","NCT04475510","Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke","Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial","HALTI","Inclusion Criteria:\n\n* Successful transcatheter PFO closure with any approved device\n* Patients ≤60 years diagnosed with a cryptogenic stroke\u002FTIA who have undergone successful transcatheter PFO closure\n\nExclusion Criteria:\n\n-\\>60 year-old\n\n* RoPE score \\\u003C6\n* Residual shunt ≥moderate following PFO closure\n* Atrial fibrillation following PFO closure\n* Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)\n* Diabetes mellitus\n* Thrombophilia (factor V Leiden, factor II mutation, anticardiolipin antibodies, lupus anticoagulant, anti-b2 glycoprotein-I antibodies, protein C deficiency, protein S deficiency)\n* Recurrent cerebrovascular event (stroke, TIA) within the year following PFO closure\n* Failure to provide signed informed consent\n* Absolute contraindications for an MRI study",true,{"count":232,"type":21},100,[24],"To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.",[30,236,237],"Ischemic Stroke","Bleeding Ulcer",[239,236,240,241],"Transcatheter Patent Foramen Ovale (PFO) closure","Bleeding","Young patients",{"date":157,"type":40},{"date":244,"type":40},"2020-07-08",{"date":246,"type":21},"2032-08-01",{"name":187,"class":106},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":259,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},"100606200","early-feasibility-study-efs-evaluating-percutaneous-repair-of-the-atrial-septum-with-a-novel-pfo-occluder-the-protea-pfo-study-100606200","NCT07172464","Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study","PROTEA-PFO","Inclusion Criteria:\n\n1. Patient must be ≥ 18 and ≤ 65 years of age\n2. Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and\u002For during Valsalva release.\n3. Ischemic stroke, defined as acute focal neurological deficit, presumed to be due to focal ischemia and confirmed by MRI or CT to have a neuroanatomically relevant cerebral infarct.\n4. Modified Rankin score (mRS) ≤ 3.\n5. Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee.\n6. Patient is willing and capable of providing informed consent.\n7. Prior to index procedure (7-day window), persons of childbearing potential must have a negative pregnancy test.\n\nExclusion Criteria:\n\n1. Other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding \\>4 mm into the lumen), large artery atherosclerotic disease proximal to the territory of the index stroke, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection, presence of left atrial appendage thrombus.\n2. Other arteriopathy of the intracranial or extracranial vessels with \\>50% stenosis proximal to the territory of the index stroke.\n3. Intracardiac thrombus or tumor.\n4. Myocardial Infarction (MI) or unstable angina within the previous 180 days.\n5. Life expectancy \\\u003C 2 years.\n6. Left ventricular aneurysm or akinesis.\n7. Moderate to severe mitral valve stenosis or severe mitral regurgitation.\n8. Aortic valve stenosis (mean gradient \\>20 mmHg) or severe regurgitation.\n9. Active endocarditis or other infection that may preclude implantation of the investigational device.\n10. Any valve vegetation or Lambl's excrescence of any left-sided valve.\n11. Left ventricular dilated cardiomyopathy with LVEF \\\u003C35%.\n12. Another source of right-to-left shunts identified at baseline, including an atrial septal defect and\u002For fenestrated septum and pulmonary arteriovenous malformation.\n13. History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker, or AICD.\n14. Severe renal failure ( Stage 4 CKD, eGFR \\\u003C30) or patient requiring dialysis.\n15. Severe liver disease (e.g., documented cirrhosis or active hepatitis).\n16. Severe lung insufficiency (e.g., need for supplemental oxygen or chronic steroid medications).\n17. Uncontrolled hypertension, defined as sustained elevated blood pressure \\>140\u002F90 mm Hg.\n18. Severe pulmonary artery hypertension, defined as pulmonary systolic pressure of \\>50mmHg.\n19. Uncontrolled hyperglycemia, defined as HbA1c value \\>8% (IFCC: \\>64 mmol\u002Fmol).\n20. Increased bleeding risk such as severe liver failure, active peptic ulcer, proliferative diabetic retinopathy, history of severe bleeding (e.g.: gastrointestinal bleeding, macroscopic hematuria, intraocular bleeding, intracranial or cerebral hemorrhage), or other history of bleeding or coagulopathy.\n21. Known hypercoagulable state that would require full anticoagulation. Minimum testing to include lupus anticoagulant, anticardiolipin antibodies, beta-2-glycoprotein, homocysteine.\n22. Subjects contraindicated for aspirin or clopidogrel.\n23. Subjects not able to discontinue anticoagulation for indications other than then index stroke.\n24. Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation or require premature discontinuation of antiplatelet regime post-implantation, as well as any severe concurrent illness that would limit life expectancy (e.g., malignancies).\n25. Currently an active subject in an investigational drug or device study that could confound the results of this study.\n26. Any significant valve dysfunction that contraindicates PFO closure or increased pulmonary vascular resistance\u002Fsevere pulmonary hypertension.\n27. Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).\n28. Any prior percutaneous cardiovascular intervention for AF ablation.",{"count":20,"type":21},[24],"The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a stroke that may be related to this heart opening. The main question it aims to answer is:\n\n• Is the P3 Occluder System safe and effective for closing a PFO in patients who have had a stroke that could be related to a PFO.\n\nParticipants will:\n\n* Undergo the procedure to implant the P3 Occluder System, if deemed appropriate.\n* Visit their doctor at 1 month, 3 months, 6 months, 1 year, and 5 years after the procedure for follow up exams.\n* Answer a phone call from study staff at 2 years, 3 years, and 4 years after the procedure to answer a survey.",[27,28,29,30,31],[30,27,29,33,34,35],"2026-03-03",{"date":262,"type":40},"2026-03-04",{"date":264,"type":40},"2025-10-09",{"date":266,"type":21},"2031-02",{"name":46,"class":47},5,{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":197,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":283,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":290,"leadSponsor":292,"locationsCount":188},"100606025","effects-of-pfo-closure-on-glymphatic-function-and-clinical-symptoms-in-patients-with-migraine-100606025","NCT07170176","Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine","The Impact of Percutaneous Patent Foramen Ovale Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine","Inclusion Criteria:\n\n1. Adults aged 18 to 60 years.\n2. Diagnosed with patent foramen ovale (PFO) with significant right-to-left shunt.\n3. For the case group: Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders (ICHD-3).\n4. For the control group: No history of migraine.\n5. Willing and able to provide written informed consent.\n6. Education level of primary school or higher.\n\nExclusion Criteria:\n\n1. Patients with a history of PFO closure or other migraine-related surgical treatments;\n2. Patients with other severe cardiac or neurological diseases, mental disorders, or psychological conditions;\n3. Patients with contraindications to closure surgery or MRI scans (e.g., severe infection, coagulation dysfunction, cardiac pacemakers, aneurysm clips, metallic foreign bodies in the eye, non-removable metal dentures, etc.);\n4. Patients unable to complete migraine symptom assessments or imaging examinations due to other reasons.",{"count":277,"type":21},150,[24],"Patent Foramen Ovale (PFO) is a common congenital heart defect. Recent studies have suggested a potential association between PFO and migraines, particularly migraine with aura. It is hypothesized that PFO may allow microemboli or vasoactive substances from venous blood to bypass pulmonary metabolism and enter the arterial system directly, potentially triggering migraines. Although PFO closure has been shown to reduce the frequency and severity of migraine attacks, its long-term efficacy and underlying mechanisms require further investigation.\n\nThis study aims to explore the characteristics of glymphatic system function in PFO patients and its relationship with migraine symptoms, as well as the impact of PFO closure on glymphatic function and its role in alleviating migraine symptoms. A case-control and self-controlled before-after study design is adopted. Two groups of participants are enrolled: a case group consisting of PFO patients with significant right-to-left shunt and migraine, and a control group comprising PFO patients with significant shunt but without migraine. According to clinical guidelines and after obtaining informed consent, eligible patients in the case group undergo percutaneous PFO closure.\n\nBy comparing migraine symptoms and glymphatic function indicators both before and after the procedure between the two groups, the interventional effect of PFO closure and its potential mechanism will be investigated. The primary endpoint is the improvement in migraine symptoms, while the secondary endpoints include glymphatic function metrics. The findings of this study will provide new theoretical insights and clinical guidance for the management of PFO-related migraines.",[281,30,282],"Migraine Disorders","Right-to-Left Shunt, Cardiac",[30,284,285,151],"Migraine","Glymphatic System","2026-01-14",{"date":288,"type":40},"2026-01-16",{"date":286,"type":40},{"date":291,"type":21},"2027-12-31",{"name":293,"class":106},"First Affiliated Hospital Xi'an Jiaotong University",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":302,"maxAge":18,"enrollmentInfo":303,"targetDuration":305,"studyType":59,"phases":4,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":188},"100415178","internal-microstructure-of-patent-foramen-ovale-related-to-stroke-100415178","NCT04686253","Internal Microstructure of Patent Foramen Ovale Related to Stroke","Internal Microstructure of Patent Foramen Ovale Related to Cryptogenic Stroke, Transient Ischemic Attack or Migraine","IMPORT","Inclusion Criteria:\n\n1. Patients aged 16 to 65 years without any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity;\n2. Documented PFO with right-to-left shunt ≥ 20 micro-bubbles by c-TCD;\n3. Stroke group: history of ischemic stroke (based on brain magnetic resonance imaging) or TIA within 6 months without other identifiable causes (Phase1);\n4. Migraine group: history of migraine headaches more than one year without other identifiable causes (Phase2);\n5. Control group: incidental finding of PFO without neurological or systemic symptoms (Phase3).\n\nExclusion Criteria:\n\n1. Any identifiable cause of ischemic stroke\u002FTIA or migraine other than PFO;\n2. History of stroke or TIA within the past one month;\n3. Presence of cardiac enlargement or dysfunction;\n4. Presence of coexisting cardiovascular structural malformations\u002Fdiseases;\n5. Presence of carotid artery lesions or coronary artery disease;\n6. Presence of deep vein thrombosis or pulmonary embolism;\n7. Presence of implanted cardiac devices;\n8. Evidence of hypercoagulable state;\n9. Allergic to contrast medium;\n10. Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation;\n11. Active endocarditis or other infections.","16 Years",{"count":304,"type":21},1200,"5 Years","This study aims to (1) investigate the internal microstructure of patent foramen ovale related to cryptogenic stroke, transient ischemic attack or migraine and determine the effectiveness of transcatheter closure in these patients; (2) evaluate the microstructural features of asymptomatic patients with PFO and make a follow-up；(3) perform an untargeted metabolomics analysis using plasma samples from right atrium and left atrium and shunt provocative test was conducted;(4) collect the blood sample from PFO tunnel;(5) cardiac CTA was performed to evaluate the position and morphology of device.",[30],[309,310,311,312,313],"patent foramen ovale","stroke","transient ischemic attack","migraine","microstructure","2025-07-17",{"date":316,"type":40},"2025-07-22",{"date":318,"type":40},"2020-12-23",{"date":320,"type":21},"2028-12-31",{"name":322,"class":323},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":331,"targetDuration":305,"studyType":59,"phases":4,"briefSummary":332,"conditions":333,"keywords":334,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":48},"100591697","pioneering-advancements-in-cardiocerebrovascular-interactions-in-the-asia-pacfic---patent-foramen-ovale-study-100591697","NCT06983795","Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study","PACIFIC-PFO","Inclusion Criteria\n\n1. Subject has experienced acute ischemic stroke or transient ischemic attack\n2. Subject is screened with presence of PFO (right-to-left shunt) on appropriate cardiac imaging (transthoracic echocardiography and\u002For transesophageal echocardiography) or transcranial Doppler bubble study\n3. Age ≥18 years\n\nExclusion Criteria\n\n1. Stroke mimics, haemorrhagic stroke or cerebral venous thrombosis\n2. Subjects with less than 3 months of follow up",{"count":114,"type":21},"A registry of patients from the Asia-Pacific region with PFO and ischemic stroke, designed to study the characteristics, investigations, treatment and outcomes using real-world data.",[236,30],[30,236],"2025-05-14",{"date":337,"type":40},"2025-05-21",{"date":339,"type":21},"2025-07",{"date":341,"type":21},"2030-12",{"name":343,"class":106},"National University Hospital, Singapore",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":48},"100589377","establishment-of-a-clinical-and-prognostic-follow-up-cohort-of-migraine-patients-with-patent-foramen-ovale-100589377","NCT06953622","Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale","Inclusion Criteria:\n\n* Meet the diagnostic criteria for migraine in the International Classification of Headache (ICHD-3);\n* Confirmation of patent foramen ovale through transthoracic echocardiography(TTE) or transesophageal echocardiography(TEE)\u002Fright heart contrast echocardiography\n* Agree to participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Can not sign the informed consent form or cooperate with follow-up.",{"count":351,"type":21},330,"To establish a headache center in China that combines clinical, imaging and laboratory examinations, explore the feasible treatment options for migraine combined with patent foramen ovale, and search for the possible influencing factors, construct models that influence prognosis.",[284,30],"2025-04-29",{"date":356,"type":40},"2025-05-01",{"date":358,"type":40},"2024-01-01",{"date":360,"type":21},"2026-12-31",{"name":362,"class":106},"Peking University Third Hospital",{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":371,"enrollmentInfo":372,"targetDuration":374,"studyType":59,"phases":4,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":48},"100528123","russian-registry-of-endovascular-closure-of-pfo-100528123","NCT06156670","Russian Registry of Endovascular Closure of PFO","Russian Registry of Endovascular Closure of Patent Foramen Ovale","ENDOVAL","Inclusion Criteria:\n\n1. Patients with an ischemic event (cryptogenic ischemic stroke, transient ischemic attack, embolism of other organs and systems) associated with a PFO;\n2. Presence of an open oval confirmed by ultrasound diagnostic methods;\n3. Age of patients from 18 years;\n4. Life expectancy of at least 1 year;\n5. Signed informed consent for endovascular closure of a PFO.\n\nExclusion Criteria:\n\n1. Inability to receive antiplatelet therapy;\n2. Presence of acute inflammatory diseases;\n3. Acute stage of cerebral circulatory failure (30 days);\n4. Myocardial infarction or aortocoronary bypass surgery within the previous 30 days;\n5. Carotid or vertebral artery dissection;\n6. Severe cardiac valve pathology;\n7. Presence of blood clots in the cardiac cavities;\n8. Refusal of the patient to participate in the study.","70 Years",{"count":373,"type":21},700,"12 Months","The study will include all patients over 18 years of age who underwent endovascular closure of patent foramen ovale in medical centers in the Russian Federation, who gave written informed consent to the closure and provided personal data as part of inpatient medical care. The project participants will be 29 medical centers in the Russian Federation, where endovascular closure of patent foramen ovale is performed.",[30],[30,310],"2025-01-27",{"date":380,"type":40},"2025-01-29",{"date":382,"type":40},"2023-12-01",{"date":384,"type":21},"2025-12-31",{"name":386,"class":323},"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":197,"enrollmentInfo":394,"targetDuration":4,"studyType":22,"phases":396,"briefSummary":397,"conditions":398,"keywords":399,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":410},"100480574","encore-pfo-closure-device---the-perform-trial-100480574","NCT05537753","Encore PFO Closure Device - The PerFOrm Trial","Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial","Inclusion Criteria:\n\n1. Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and\u002For during Valsalva release\n2. Cryptogenic stroke within the last 270 days; stroke is defined as acute focal neurological deficit, presumed to be due to focal ischemia, and confirmed by MRI or CT to be a new, neuroanatomically relevant cerebral infarct\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years and age \\>60 years\n2. Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels\n3. Intracardiac thrombus or tumor\n4. Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina\n5. Left ventricular aneurysm or akinesis\n6. Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitral regurgitation\n7. Aortic valve stenosis (gradient \\>40 mmHg) or severe aortic valve regurgitation\n8. Mitral or aortic valve vegetation or prosthesis\n9. Left ventricular ejection fraction \\\u003C35%\n10. Other identifiable cause of stroke, including but not limited to aortic arch plaques (protruding \\>4 mm into the lumen), large artery atherosclerotic disease, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection\n11. Evidence of a hypercoagulable disorder requiring anticoagulation therapy; this determination will be based on the evaluation of: anticardiolipin antibody (Ab) of the IgG or IgM type, Lupus anticoagulant, B2-glycoprotein-1 Ab, and fasting plasma homocysteine\n12. Another source of right-to-left shunts identified at baseline, including an atrial septal defect and\u002For fenestrated septum\n13. Any history of atrial fibrillation\u002Fatrial flutter (chronic or intermittent)\n14. Active endocarditis or other untreated infections\n15. Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis (eGFR less than 30)\n16. Severe liver disease (ALT 3X ULN) or documented cirrhosis\n17. Lung disease requiring continuous home oxygen\n18. Uncontrolled hypertension, defined as sustained elevated blood pressure \\>160\u002F90 mm Hg on medication\n19. Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent test which must have been collected within the last year)\n20. Anatomical or physiological structures that do not permit TEE\n21. Anticipated need for treatment of structural cardiac defects other than PFO\n22. Concomitant cardiac anomalies requiring an operative procedure\n23. Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis)\n24. Hypersensitivity to contrast medium or nickel\n25. Contraindication to aspirin or clopidogrel\n26. The required sheaths cannot be passed through the relevant vessels for access to the PFO\n27. Vulnerable patient (e.g., incarcerated or cognitively challenged adults); see Section 7.2.1\n28. Subject is unable or unwilling to provide informed consent\n29. Subject is unable to comply with the protocol\n30. Any other clinical reasons for which the patient would not be an appropriate candidate for the study, as determined by the site investigators",{"count":395,"type":21},500,[24],"The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.",[30,29],[400,148],"PFO closure","2024-09-11",{"date":403,"type":40},"2024-09-19",{"date":405,"type":40},"2023-07-12",{"date":407,"type":21},"2030-10",{"name":409,"class":47},"Encore Medical Inc.",8,{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":4},"100547836","long-term-procedural-and-device-related-complications-of-pfo-closure-100547836","NCT06413147","Long-term Procedural and Device Related Complications of PFO Closure","Inclusion Criteria:\n\n* All patients who underwent PFO closure\n\nExclusion Criteria:\n\n* Unable to complete or adhere to the study",{"count":232,"type":21},"We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.",[30],"2024-05-13",{"date":422,"type":40},"2024-05-14",{"date":424,"type":21},"2024-05-30",{"date":426,"type":21},"2029-05-30",{"name":428,"class":106},"Xuanwu Hospital, Beijing",{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":16,"minAge":436,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":48},"100534280","aware-registry-wearable-ecg-in-structural-heart-interventions-100534280","NCT06236776","AWARE Registry: Wearable ECG in Structural Heart Interventions","Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry","Inclusion Criteria:\n\n* Adult ≥ 19 year-old\n* Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale\n* Patients provided with the written, informed consent to participate in this study\n\nExclusion Criteria:\n\n* Patients who had paroxysmal, persistent, or chronic AF\n* Life expectancy \\\u003C 12 months\n* Subject who the investigator deems inappropriate to participate in this study","19 Years",{"count":277,"type":21},"This study is a multi-center (Sinchon Severance hospital \u002F Gangnam Severance hospital), prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type atrial septal defect or Patent foramen ovale. Transthoracic echocardiography will be performed before the procedure, immediately after, and at 6, 18, 30 months after the procedure. Wearable ECG monitoring (\\> 3 days) will be performed before the procedure or immediately after procedure. Demographic, laboratory, hemodynamic data during procedure, and non-invasive imaging dat are obtained.",[121,30],"2024-01-24",{"date":442,"type":40},"2024-02-01",{"date":444,"type":21},"2024-02",{"date":446,"type":21},"2028-06",{"name":448,"class":106},"Yonsei University",{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":197,"enrollmentInfo":456,"targetDuration":4,"studyType":22,"phases":458,"briefSummary":459,"conditions":460,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":469},"100498748","safety-and-efficacy-of-cera-patent-foramen-ovale-occluders-100498748","NCT05774288","Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.","A Prospective, Multi-center, Randomized, Controlled Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.","Inclusion Criteria:\n\n1. Patients aged 18-60 years;\n2. Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent;\n3. Patent foramen ovale was confirmed by at least one of the following conditions exists:\n\n   1. Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE);\n   2. The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD);\n4. It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists:\n\n   1. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors;\n   2. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale;\n   3. Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;\n   4. Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy.\n\nExclusion Criteria:\n\n1. Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (\\> 50%);\n2. Large cerebral infarction occurred within 4 weeks (MR\u002FCT or DWI image ASPECTS score \\\u003C6 points or infarction volume ≥70 ml or infarction area \\> 1\u002F3 middle cerebral artery blood supply area);\n3. Patients with intracardiac thrombosis or tumor, intracardiac vegetations;\n4. Acute myocardial infarction or unstable angina within 6 months;\n5. Left ventricular aneurysm formation or left ventricular wall movement disorder;\n6. Mitral\u002Faortic disease: including mitral stenosis or severe mitral regurgitation of any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve vegetations or prior valve replacement surgery;\n7. Dilated cardiomyopathy, LVEF \\\u003C 35%, or other severe heart failure;\n8. Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;\n9. Atrial fibrillation\u002Fatrial flutter (chronic or intermittent);\n10. Pregnant or planning to become pregnant during the trial;\n11. Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;\n12. Pulmonary hypertension or patent foramen ovale was a special channel;\n13. Liver and kidney function impairment (ALT or AST \\> 3 times the upper limit of normal value, serum creatinine (Cr) \\> 2 times the upper limit of normal value);\n14. Uncontrolled hypertension (\\> 180\u002F100 mmHg);\n15. Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;\n16. Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;\n17. The investigator determined that the patient was not suitable for implantation of PFO occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and the size of the foramen ovale ≥5mm) or the patient has contraindications for implantation of PFO occluder;\n18. Thrombosis exists at the location or route of implantation;\n19. Malignant neoplasms or other diseases with a life expectancy of less than 2 years;\n20. Patients who could not be followed up during the trial;\n21. Participate in clinical trials of other drugs or medical devices within three months.",{"count":457,"type":21},244,[24],"To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;",[30,29],"2023-08-31",{"date":463,"type":40},"2023-09-01",{"date":465,"type":40},"2023-06-08",{"date":467,"type":21},"2029-06-30",{"name":75,"class":47},14,{"id":471,"slug":472,"hasResults":11,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":48},"100466978","study-on-the-safety-and-effectiveness-of-the-snowytm-pfo-closure-system-100466978","NCT05360771","Study on the Safety and Effectiveness of the SnowyTM PFO Closure System","A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Effectiveness of the SnowyTM PFO Closure System in Plugging Patent Foramen Ovale","Inclusion Criteria:\n\n1. Age: 18 to 65 years old, regardless of gender\n2. Transthoracic echocardiographic contrast echocardiography (cTTE) confirmed the presence of PFO and at least moderate (see above definition) RLS (in Valsalva active\u002Fresting state)\n3. Existence of at least one of the following conditions： 1) Unexplained stroke or TIA 2) intractable or chronic migraine\n4. The subjects are informed of the nature of the study and agreed to all requirements for participation in the study, signed the informed consent form, and agree to complete the follow-up and follow-up examination\n\nExclusion Criteria:\n\n1. Patients have definite causes of stroke unrelated to the PFO\n2. RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt\n3. Atrial fibrillation or atrial flutter\n4. Mitral and aortic stenosis or severe regurgitation\n5. Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy\n6. Active endocarditis or other untreated infectious diseases\n7. Left ventricular ejection fraction (LVEF) \\\u003C 40%, or NYHA cardiac function grade III-IV\n8. Uncontrollable hypertension\n9. Previous intracardiac surgery\n10. Myocardial infarction or unstable angina pectoris within 6 months\n11. Contraindications to anticoagulants or antiplatelet drugs\n12. High risk of bleeding\n13. severe liver function impairment（alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value）\n14. Serum creatinine greater than 2 times the upper limit of normal or with any history of renal dialysis or renal transplantation\n15. Severe pulmonary disease including pulmonary hypertension (clinical diagnosis)\n16. Nickel or contrast allergy\n17. Active or planned (within 12 months) pregnancy, or lactating female patients\n18. Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months\n19. Psychiatric conditions that may interfere with medical compliance and compliance with follow-up\n20. Concomitant participation in other clinical trials\n21. The investigator determines that the patient is unsuitable because of reasons not listed but thought to interfere with safe trial participation",{"count":478,"type":21},242,[24],"To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale",[30],"2023-06-05",{"date":484,"type":40},"2023-06-07",{"date":486,"type":21},"2023-10-20",{"date":488,"type":21},"2027-12-20",{"name":490,"class":47},"Hangzhou Dinova EP Technology Co., Ltd",{"id":492,"slug":493,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":499,"enrollmentInfo":500,"targetDuration":502,"studyType":59,"phases":4,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":48},"100384660","canadian-adult-congenital-heart-disease-intervention-registry-100384660","NCT04288596","Canadian Adult Congenital Heart Disease Intervention Registry","The Canadian Registry for Adults With Congenital Heart Disease Interventions","C-ACHDiR","Inclusion Criteria:\n\n* participants must be 18 years or older referred for intervention for one of five ACHD conditions including diagnostic catheterization for complex ACHD patients (Tetralogy of Fallot, Fontan, and transposition of the great vessels, single ventricle, truncus arteriosus); transcatheter closure of atrial septal defects; transcatheter closure of patent foramen ovale; coarctation of aorta stenting, and percutaneous pulmonary valve implantation.\n\nExclusion Criteria:\n\n* participants below the age of 18\n* participants residing outside of Canada","110 Years",{"count":501,"type":21},9000,"10 Years","The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of care processes and outcomes in five most common ACHDi interventions by enabling prospective and retrospective registry-based studies to answer important clinical practice and policy-relevant questions.",[121,30,505,506,507,508,509],"Tetralogy of Fallot","Fontan","Coarctation of Aorta","Transposition of Great Vessels","Percutaneous Pulmonary Valve Implantation","2020-02-27",{"date":512,"type":40},"2020-02-28",{"date":514,"type":21},"2020-04-01",{"date":516,"type":21},"2030-04-01",{"name":518,"class":106},"University Health Network, Toronto"]