[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pfo\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pfo":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,70],{"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":18,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"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":63,"type":40},"2026-03-04",{"date":65,"type":40},"2025-10-09",{"date":67,"type":21},"2031-02",{"name":46,"class":47},5,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":81,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100619325","multimodal-brain-function-in-migraine-patients-with-patent-foramen-ovale-100619325","NCT07343154","Multimodal Brain Function in Migraine Patients With Patent Foramen Ovale","A Prospective Study on the Effects of Percutaneous Patent Foramen Ovale Closure on Multimodal Brain Function, Cognition, and Emotion in Patients With Migraine and Patent Foramen Ovale","NEURO-PFO","Inclusion Criteria:\n\n* Age ≥18 years and \\\u003C60 years at Screening\u002FBaseline.\n* Diagnosis of migraine with aura established by a neurologist according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.\n* Migraine history ≥1 year AND, during the 3-month screening\u002Frun-in period, an average of ≥4 migraine days per month; participant is willing and able to complete a headache diary, which will be reviewed by the investigator prior to enrollment.\n* Patent foramen ovale (PFO) identified by transthoracic echocardiography (TTE) and confirmed by contrast transesophageal echocardiography (cTEE), with at least moderate atrial-level right-to-left shunt (RLS) during Valsalva maneuver.\n* RLS grading by microbubbles in the left-sided cardiac chambers per frame on single-frame images:\n* No RLS: 0 microbubbles\n* Grade I (small): 1-10 microbubbles\u002Fframe\n* Grade II (moderate): 11-30 microbubbles\u002Fframe\n* Grade III (large): \\>30 microbubbles\u002Fframe or near-complete opacification of the left chambers (\"hazy\" appearance)\n* Prior use of at least three different classes of migraine preventive therapies with either \\\u003C50% improvement in migraine frequency during treatment OR intolerable adverse effects.\n* At least two therapies must be from different categories among (a-f); the third may be one of (g-j):\n\n  1. Beta-blockers\n  2. Tricyclic antidepressants\n  3. Verapamil or flunarizine\n  4. Sodium valproate (or divalproex sodium)\n  5. Topiramate\n  6. Other anticonvulsants\n  7. Any therapy supported as effective by at least one positive randomized controlled trial\n  8. Nonsteroidal anti-inflammatory drugs (NSAIDs)\n  9. Metabolic agents (e.g., vitamin B2 or coenzyme Q10)\n  10. Traditional Chinese medicine\n* Participant has been on a stable daily dose regimen of preventive headache medication for ≥3 consecutive months prior to enrollment (to be verified during screening).\n* Written informed consent provided and willingness to comply with study procedures and follow-up schedule.\n\nExclusion Criteria:\n\n* Expected life expectancy ≤1 year at Screening\u002FBaseline.\n* Secondary migraine attributable to other causes.\n* History of transient ischemic attack (TIA), stroke, or intracranial hemorrhage.\n* Investigator-determined anatomical findings on TEE that are unfavorable for successful PFO occluder deployment or any contraindication to device implantation, including (but not limited to):\n* Inability to undergo\u002Fcomplete TEE\n* Vascular access unable to accommodate the delivery system\n* Requirement for transseptal puncture\n* Requirement for implantation of more than one occluder\n* Defect size estimated too large for successful closure\n* Potential interference between the occluder and other intracardiac structures\n* Anatomy preventing adequate apposition of the occluder discs to the atrial septum\n* Allergy to any component\u002Fmaterial of the AMPLATZER™ PFO Occluder (e.g., nickel allergy).\n* Current or past diagnosis of severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depressive disorder), or unstable psychiatric illness defined as psychiatric hospitalization, medication dose adjustment, or marked symptom fluctuation within the past 6 months.\n* Neurological and\u002For neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis), uncontrolled epilepsy\u002Fseizures within the past 1 year, central nervous system tumor, or history of traumatic brain injury.\n* History of myocardial infarction.\n* History of pacemaker implantation, atrial septal defect (ASD) closure, or left atrial appendage (LAA) closure.\n* Intracardiac right-to-left shunt due to causes other than PFO.\n* Contraindications to aspirin and\u002For clopidogrel, including significant thrombocytopenia, major trauma, acute clinically significant bleeding, or allergy to study medications.\n* Hepatic impairment defined as PT and\u002For APTT \\>2× the upper limit of normal (ULN) OR total bilirubin ≥3 mg\u002FdL.\n* Poorly controlled diabetes mellitus at Screening\u002FBaseline (as judged by the investigator).\n* Poorly controlled atrial fibrillation at Screening\u002FBaseline (as judged by the investigator).\n* Poorly controlled hypertension at Screening\u002FBaseline, defined as blood pressure \\>160\u002F90 mmHg despite appropriate pharmacologic treatment.\n* Active autoimmune disease at Screening\u002FBaseline (e.g., systemic lupus erythematosus, rheumatoid arthritis, polyarteritis nodosa, central nervous system granulomatous vasculitis).\n* Active infection at Screening\u002FBaseline that cannot be fully resolved prior to enrollment.\n* Alcohol abuse or drug dependence at Screening\u002FBaseline.\n* Ongoing anticoagulation therapy that cannot be discontinued.\n* Unable to accurately describe headache status and\u002For unable to complete\u002Fmaintain a headache diary.\n* Currently participating in another device or drug clinical trial in which the primary endpoint has not been reached, or that may clinically confound this study's endpoints, or that prohibits co-enrollment.\n* Pregnant or planning pregnancy during the study period.\n* Planned elective surgery during the study period.\n* Any medical condition or circumstance that, in the investigator's opinion, poses a significant risk to participant safety, confounds study results, or interferes with study participation.\n* Any other medical or non-medical reason that, in the investigator's opinion, makes the participant unsuitable (e.g., inability to comply with study procedures\u002Fvisits, plans to relocate during the study period).","60 Years",{"count":80,"type":21},45,"3 Years","OBSERVATIONAL","This investigator-initiated, single-center prospective study is designed to clarify how patent foramen ovale (PFO) relates to brain function abnormalities in patients with drug-refractory migraine with aura (MA), and whether percutaneous PFO closure is associated with measurable, longitudinal improvements in neurophysiological and neuroimaging markers as well as clinical symptoms.\n\nThe study addresses two core questions: (1) Do MA patients with clinically significant right-to-left shunt due to PFO demonstrate distinct resting-state brain function patterns-captured by high-density EEG (hdEEG), resting-state functional MRI (rs-fMRI), and standardized cognitive testing-compared with MA patients without PFO? (2) In MA patients with PFO who undergo clinically indicated percutaneous PFO closure, do these multimodal brain function measures change over time after closure (pre-procedure vs 1, 6, and 12 months), and are such changes accompanied by improvement in migraine burden, quality of life, and mood\u002Fanxiety symptoms? The protocol includes two phases. In Phase 1 (cross-sectional comparison), two groups are evaluated at baseline: MA with PFO (PFO+\u002FMA+) and MA without PFO (PFO-\u002FMA+). Participants complete hdEEG and rs-fMRI to characterize whole-brain power spectral density and connectivity, and undergo MATRICS Consensus Cognitive Battery (MCCB) testing and validated symptom\u002Fpsychological assessments (e.g., MIDAS, MSQ v2.1, PHQ-9, GAD-7, RoPE). In Phase 2 (prospective self-controlled cohort), eligible PFO+\u002FMA+ participants who proceed to percutaneous PFO closure as part of routine clinical care are followed longitudinally with repeated multimodal assessments at pre-closure baseline and post-closure 1, 6, and 12 months. This phase evaluates within-person trajectories of resting-state brain function (hdEEG, rs-fMRI) and cognition\u002Femotion measures, together with migraine diary-based outcomes and patient-reported quality of life\u002Fdisability and mood\u002Fanxiety scales. Key eligibility focuses on adults aged 18-65 years with ICHD-3-defined migraine with aura and a history of frequent migraine (≥4 migraine days\u002Fmonth during screening) despite prior preventive therapy trials; the PFO group requires echocardiographic confirmation of PFO with at least moderate right-to-left shunt (e.g., during Valsalva on contrast TEE), consistent with the study's focus on clinically meaningful shunt physiology.\n\nThe primary endpoints are multimodal brain function and cognition measures. In Phase 1, the main outcomes include between-group differences in MCCB composite score, rs-fMRI whole-brain functional connectivity strength, and hdEEG spectral power across frequency bands (delta\u002Ftheta\u002Falpha\u002Fbeta\u002Fgamma) and theta-band connectivity quantified by whole-brain phase-lag index (PLI). In Phase 2, the primary outcome is the 12-month post-closure change in these multimodal resting-state brain function measures, reflecting dynamic neural recovery or reorganization after PFO closure.\n\nSecondary outcomes include changes in migraine clinical metrics (monthly migraine days, attack frequency and duration, and complete remission rate), migraine-specific quality of life (MSQ v2.1), disability (MIDAS), and depression\u002Fanxiety symptom scores (PHQ-9 and GAD-7) over follow-up. Safety outcomes include adverse events potentially related to the closure procedure and routine post-procedural anti-thrombotic therapy, captured throughout follow-up.",[27,85,86,87],"Cognitive","Cognitive Functions","Migraine","NOT_YET_RECRUITING","2026-01-06",{"date":91,"type":40},"2026-01-15",{"date":93,"type":21},"2026-02-01",{"date":95,"type":21},"2029-06-30",{"name":97,"class":98},"Second Xiangya Hospital of Central South University","OTHER"]