[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cryptogenic-stroke\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cryptogenic-stroke":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,76,97,129,155,180,207],{"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":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"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":58,"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.",[30,29,62,63,64],"Older Patients","Medical Treatment","Recurrent Stroke","2026-03-23",{"date":67,"type":40},"2026-03-27",{"date":69,"type":40},"2024-06-18",{"date":71,"type":21},"2037-10-01",{"name":73,"class":74},"Josep Rodes-Cabau","OTHER",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"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":90,"type":40},"2026-03-04",{"date":92,"type":40},"2025-10-09",{"date":94,"type":21},"2031-02",{"name":46,"class":47},5,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":107,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100368267","observation-of-clinical-routine-care-for-patients-with-biotronik-implantable-cardiac-monitors-icms-100368267","NCT04075084","Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)","BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)","BIOSTREAM-ICM","Inclusion Criteria:\n\n* Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM)\n* Patient is able to understand the nature of the registry and to provide written informed consent.\n* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.\n\nExclusion Criteria:\n\n* Patient is pregnant or breast feeding.\n* Patient is less than 18 years old.\n* Patient is participating in another interventional clinical investigation other than the submodules of BIO\\|STREAM.ICM",{"count":106,"type":21},1400,"3 Years","OBSERVATIONAL","This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.",[111,112,113,114,29],"Tachycardia","Atrial Fibrillation","Syncope","Bradycardia",[116,117,118],"Implantable Cardiac Monitor","BIOMONITOR III","BIOMONITOR IV","2025-09-26",{"date":121,"type":40},"2025-10-01",{"date":123,"type":40},"2019-10-28",{"date":125,"type":21},"2027-08-30",{"name":127,"class":47},"Biotronik SE & Co. KG",31,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":137,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":48},"100482726","smartwatch-and-external-holter-monitoring-to-detect-atrial-fibrillation-in-patients-with-cryptogenic-stroke-100482726","NCT05565781","Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke","Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke","SMARTTHUNDER","Inclusion Criteria:\n\n* Age greater to or equal to 55 years\n* Patients with diagnosis of cryptogenic stroke after a basic study that included neuroimaging, extra\u002Fintracranial vascular evaluation, 24-hour monitoring, and echocardiogram\n* Patients with acute cortical infarction with the presence of intracranial occlusion (preferably)\n* Modified Rankin Scale (mRS) lower to 4\n\nExclusion Criteria:\n\n* Diagnosis of lacunar infarction or transient ischemic attack (TIA)\n* Diagnosis of stroke of known source: atherothrombotic due to moderate or severe symptomatic extra\u002Fintracranial stenosis, major cardioembolic cause (atrial fibrillation, anterior or apical ventricular akinesis, causal PFO, post-AMI, flutter or mitral stenosis), unusual cause (thrombophilia, arterial dissection symptomatic, toxic)\n* Use of pacemakers\n* Circumstances that may preclude the clinical follow-up or reduce the possibilities of obtaining data to achieve the objectives of the study and\u002For limit contact with the investigator (for example, transfer to a social health center)\n* Unwillingness to the use of cardiac monitoring wearable devices\n* Not understanding study procedures","55 Years",{"count":139,"type":21},100,[24],"Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Currently, there are non-invasive monitoring devices such as the textile Holter that have proven to be useful for monitoring for up to 30 days but not longer. Another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.",[143,29],"Paroxysmal Atrial Fibrillation",[145],"Wearable Electronic Devices","2025-04-02",{"date":148,"type":40},"2025-04-04",{"date":150,"type":40},"2022-03-28",{"date":152,"type":21},"2026-09-01",{"name":154,"class":74},"Hospital Universitari Vall d'Hebron Research Institute",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":5},"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","60 Years",{"count":164,"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],[169,170],"PFO closure","Stroke","2024-09-11",{"date":173,"type":40},"2024-09-19",{"date":175,"type":40},"2023-07-12",{"date":177,"type":21},"2030-10",{"name":179,"class":47},"Encore Medical Inc.",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":48},"100557796","atrial-anomalies-predict-silent-atrial-fibrillation-detected-by-implantable-cardiac-monitor-in-cryptogenic-stroke-100557796","NCT06542770","Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke","Subtle Ultrasound Atrial Anomalies Predicts the Early Diagnosis of Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Patients With Cryptogenic Stroke. A Randomized Trial","CRIPTO-FAST","Inclusion Criteria:\n\n* Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023\n* Age between 50 and 89 years;\n* Undetermined origin at hospital admission according to the SSS-TOAST criteria (2):\n\n  1. Absence of major structural heart disease by cardiac ultrasound (normal global and segmental left ventricle contraction, absence of valvular\u002Frheumatic disease, absence of intracardiac shunts)\n  2. Absence of AF during 48h ECG-monitoring\n  3. Absence of major anomalies in the supra-aortic trunks ultrasound.\n\nExclusion Criteria:\n\n1. Patients with a history of hemorrhagic stroke;\n2. Presence with prior atrial fibrillation or atrial flutter;\n3. Permanent contraindication or indication for OAC for other reasons;\n4. Recent (\\\u003C1 month) major surgery or cardiac events;\n5. Presence of severe cardiac abnormalities;\n6. Patients with life expectancy \\\u003C1 year or severe stroke (modified Rankin Scale \\> 4).","50 Years","89 Years",{"count":139,"type":21},[24],"Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF.\n\nThe purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.",[143,194,195,29],"Cardiac Rhythm Disorder","Left Atrial Dilatation",[197],"Atrial strain. Implantable cardiac monitor","2024-08-02",{"date":200,"type":40},"2024-08-07",{"date":202,"type":40},"2021-01-01",{"date":204,"type":21},"2024-12",{"name":206,"class":74},"Parc de Salut Mar",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":162,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"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":215,"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":221,"type":40},"2023-09-01",{"date":223,"type":40},"2023-06-08",{"date":225,"type":21},"2029-06-30",{"name":227,"class":47},"Lifetech Scientific (Shenzhen) Co., Ltd.",14]