[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pfo---patent-foramen-ovale\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pfo---patent-foramen-ovale":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,76,123,144,175,200],{"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":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100348771","gore-cardioform-septal-occluder-and-antiplatelet-medical-management-for-reduction-of-recurrent-stroke-in-patients-with-patent-foramen-ovale-pfo-the-reduce-post-approval-study-100348771","NCT03821129","GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study","REDUCE PAS","Inclusion Criteria:\n\n* Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment.\n* Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and\u002For transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.\n* Patient is able to tolerate antiplatelet therapy\n* Note: Additional Inclusion Criteria may apply\n\nExclusion Criteria:\n\n* History of or ongoing atrial fibrillation\u002Fflutter\n* Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including mitral valve stenosis), severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, vasculitis, pre-existing non-vascular neurologic disorders, pulmonary arteriovenous malformations, prior intracranial hemorrhage, severe disability related to prior stroke, autoimmune disorders that would increase the risk of stroke or thromboembolism, or associated with increased risk of infection or procedural complications, in the opinion of the investigator, left ventricular ejection fraction of \\\u003C40%, coexistent cause or intra-cardiac shunting (e.g. VSD or ASD)\n* Previous Myocardial Infarction\n* Rankin Scale sore greater than or equal to 3 at the time of procedure\n* Active infection that cannot be treated successfully prior to enrollment\n* Neurological deficits not due to stroke that may affect the patient's neurologic assessments\n* Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure\n* Sensitivity or contraindication to all proposed medical treatments or any device components\n* Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment.\n* Indications outside the parameters accepted for placement of GSO, including extensive congenital cardiac anomalies and defect diameters considered too large for closure with the device.\n* Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder\n* Need for concomitant procedure(s) that may confound detection of adverse events related to device placement\n* Note: Additional Exclusion Criteria may apply","70 Years",{"count":58,"type":21},636,[24],"This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.",[62,28],"Stroke",[64,30,27,62,65],"Occluder","Gore Septal Occluder","2026-04-28",{"date":68,"type":40},"2026-05-05",{"date":70,"type":40},"2019-07-25",{"date":72,"type":21},"2031-10",{"name":74,"class":47},"W.L.Gore & Associates",45,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100561461","abbott-structural-heart-device-registry-100561461","NCT06590467","Abbott Structural Heart Device Registry","SH-Registry","Inclusion Criteria:\n\n1. Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.\n2. Subject is willing and able to comply with the site's standard of care follow-up schedule.\n3. Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC\u002FIRB recommendations regarding consent and the protection of personal data must be followed.\n\nExclusion Criteria:\n\n1\\. Subject is participating in another clinical study that would affect the results of this Registry.",{"count":84,"type":21},2500,"OBSERVATIONAL","The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017\u002F745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.",[88,89,90,28,91,92],"Heart Diseases","ASD - Atrial Septal Defect","VSD - Muscular Ventricular Septal Defect","PIVSD - Post Infarct Muscular Ventricular Septal Defect","Valvular Heart Disease",[94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112],"Amplatzer","Amplatzer Septal Occluder","Amplatzer Multi-fenestrated (Cribriform) Occluder","Amplatzer Duct Occluder","Amplatzer Piccolo Occluder","Amplatzer Muscular VSD Occluder","Amplatzer Post-Infarct VSD Occluder","Amplatzer Talisman","Amplatzer TorqVue Delivery System","Amplatzer Sizing Balloon","Amplatzer Guidewire","Amplatzer Occluder devices","Surgical Valves","Epic Plus Aortic Valve","Epic Plus Mitral Valve","Epic Plus Supra Aortic Valve","Epic Max Aortic Valve","Bioprosthetic heart valve","Surgical tissue heart valve","2026-04-07",{"date":115,"type":40},"2026-04-13",{"date":117,"type":40},"2024-08-21",{"date":119,"type":21},"2039-11",{"name":121,"class":47},"Abbott Medical Devices",28,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"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":137,"type":40},"2026-03-04",{"date":139,"type":40},"2025-10-09",{"date":141,"type":21},"2031-02",{"name":46,"class":47},5,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":48},"100624808","non-invasive-detection-of-pulmonary-right-to-left-shunts-using-the-sonas-ultrasound-device-100624808","NCT07414446","Non-Invasive Detection of Pulmonary Right-to-Left Shunts Using the SONAS Ultrasound Device","Novel Approach For The Non-Invasive Detection of Pulmonary Right-to-Left Shunts","SONAS","Inclusion Criteria:\n\n* Age 18 years or older.\n* Suspected or confirmed hereditary hemorrhagic telangiectasia (HHT).\n* Incidentally: Patients who have experienced cryptogenic stroke\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Known or suspected fracture(s) of the temporal \u002F parietal skull bones, or with open skin injuries in the anatomical area of the temporal \u002F parietal lobes.\n* Patients with known metal skull implants in the anatomical area of the temporal \u002F parietal bones, or with anatomical formation of the head or ear tha may interfere with proper headset placement.\n* Patients with known allergies or reactions to parabens, which are present in the gel pad material of the applied part.",{"count":153,"type":21},40,[24],"The goal of this clinical trial is to learn how well the SONAS ultrasound device can detect right-to-left shunts of adults with hereditary hemorrhagic telangiectasia (HHT) who are already scheduled for a contrast bubble echocardiogram (TTCE). The main questions it aims to answer are:\n\n1. How accurately does SONAS detect right-to-left shunts compared to the standard TTCE test?\n2. Can SONAS results help tell the difference between shunts in the heart and shunts in the lungs?\n\nParticipants will wear a headband with the SONAS device on the head while they undergo their routine TTCE bubble test. They will receive the usual contrast (agitated saline) through a vein, and both SONAS and TTCE signals will be recorded at the same time. There will be one examination in rest, and one during a breathing exercise (the Valsalva manoeuvre).",[157,28,158],"Hereditary Haemorrhagic Telangiectasia","Pulmonary Arteriovenous Malformation",[160,158,161,162,163,164,30,29],"Hereditary Hemorrhagic Telangiectasisa","Right-to-Left Shunt","Contrast Echocardiography","Transcranial Ultrasound","Microbubbles","2026-02-10",{"date":167,"type":40},"2026-02-17",{"date":169,"type":40},"2026-01-07",{"date":171,"type":21},"2026-04-01",{"name":173,"class":174},"St. Antonius Hospital","OTHER",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100531751","a-comparison-of-biodegradable-and-metal-occluders-in-patients-with-pfo-and-migraine-100531751","NCT06203873","A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine","BioMetal","Inclusion Criteria:\n\n1. Age 18-65\n2. Diagnosed migraine by ICHD-3\n3. History of migraine longer than 1 year, and symptoms severely disturbing daily life.\n4. TCD\u002FTTE\u002FTEE diagnosed patent foramen ovale with right to left shunt\n5. Willing to participant and agree to follow-ups\n6. Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%.\n\nExclusion Criteria:\n\n1. Migraine caused by other reason\n2. Had TIA\u002Fstroke history\n3. With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.\n4. With contraindication to PFO occlusion",{"count":183,"type":21},400,[24],"Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Mechanisms linking PFO to migraine include cortical spreading depression, vascular active substance theory, impaired cerebral autoregulation, and genetic susceptibility. Understanding these mechanisms holds promise for overcoming challenges in the prevention and treatment of migraines in PFO patients. At least 11 observational studies, comprising 1,632 subjects, described the efficacy of PFO closure in cryptogenic stroke. Of these, 34% had migraines, and percutaneous PFO closure reportedly reduced migraine days by 81% (with a reduction of over 50% in monthly migraine days). Prospective randomized controlled trials (PRIMA and PREMIUM trials) assessing the Amplatzer® PFO Occluder showed significant benefits in most secondary endpoints, with a pooled analysis indicating its safety and effectiveness compared to medical therapy.While traditional metal PFO closure studies suggest symptom relief, reports also mention potential new-onset or worsened migraines post-closure. Proposed mechanisms include platelet activation, microthrombus formation, nickel allergy, and septal deformation or stretching inducing the release of migraine-related vascular active substances. However, these theories are closely tied to the presence of permanent metal implants.\n\nAddressing these concerns, the MemoSorb® biodegradable PFO Occluder system, approved by the National Medical Products Administration (NMPA) in September 2023, offers an innovative solution. Developed collaboratively by the National Biomedical Materials Engineering Technology Research Center, Professor Wang Yunbing\\'s team, Professor Pan Xiangbin\\'s team from Fuwai Hospital, Chinese Academy of Medical Sciences, and HeartTech Medical, this groundbreaking technology represents a shift from metal to degradable materials. The occluder serves as a temporary bridge post-implantation, gradually degrading with endothelialization, facilitating comprehensive self-repair. This intervention concept theoretically avoids the lifelong complications associated with traditional metal occluders, effectively reducing postoperative symptoms like migraines and dizziness.\n\nTo assess and compare the treatment outcomes, especially in relieving migraines, a prospective, single-blind, randomized controlled study has been designed for patients with patent foramen ovale and migraine, comparing the novel biodegradable occluder with the metal occluder.",[28,187,188,189],"Migraine","Migraine Headache","Migraine Headache, With or Without Aura","2025-11-27",{"date":192,"type":40},"2025-12-04",{"date":194,"type":40},"2024-03-01",{"date":196,"type":21},"2026-03-01",{"name":198,"class":174},"Chinese Academy of Medical Sciences, Fuwai Hospital",2,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":219,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":48},"100562660","wso-beat-stroke-initiative-100562660","NCT06606054","WSO BEAT STROKE Initiative","WSO - The Brain and hEart globAl iniTiative (BEAT) Stroke","BEAT STROKE","Inclusion Criteria:\n\n* Patients with ischemic stroke or TIA of any etiology.\n\nExclusion Criteria:\n\n* N\u002FA",{"count":209,"type":21},2400,[24],"The WSO Brain and hEart globAl iniTiative - STROKE (BEAT-STROKE) is a cluster randomized controlled trial, testing whether an educational and implementation Neurocardiology tool can improve adherence to best practice recommendations for secondary stroke prevention of cardioembolic strokes, as defined by the WSO Systematic Review and Synthesis of Global Stroke Guidelines or more recent high-quality evidence published after the last stroke guidelines1",[62,28,213],"Atrial Fibrillation (AF)",[215,216,217,218],"cardiac monitoring","stroke","atrial fibrillation","pfo closure","NOT_YET_RECRUITING","2025-03-27",{"date":222,"type":40},"2025-04-02",{"date":224,"type":21},"2025-07",{"date":226,"type":21},"2026-12",{"name":228,"class":174},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"]