[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Josep Rodes-Cabau\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,79,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100640284","evaluation-of-a-management-algorithm-for-tavi-patients-with-concomitant-mitral-or-tricuspid-regurgitation-100640284",false,"NCT07623083","Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation","Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation","MASTER-TAVI II","Inclusion Criteria:\n\n* Age \\>18 years.\n* Patients with severe AS undergoing transarterial TAVI.\n* Concomitant significant MR and\u002For TR (≥3+).\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year due to noncardiac conditions.\n* Any prior mitral or tricuspid valve surgery.\n* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n* Active endocarditis.\n* Subjects in whom transesophageal echocardiography is contraindicated or high risk.","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.\n\nMany patients undergoing TAVI also have leakage of the mitral valve and\u002For tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.\n\nIn some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.\n\nThis study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and\u002For tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.\n\nThe study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and\u002For tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.\n\nThe main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.\n\nThe results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.",[25,26,27,28],"Aortic Stenosis","Mitral Regurgitation","Tricuspid Regurgitation","Transcatheter Aortic Valve Implantation (TAVI)",[30,31,32,33,34,35,36],"Aortic stenosis","Transcatheter aortic valve implantation (TAVI)","Multivalvular heart disease","Mitral regurgitation","Tricuspid regurgitation","Structural heart disease","Valve disease management algorithm","NOT_YET_RECRUITING","2026-05-28",{"date":40,"type":41},"2026-06-03","ACTUAL",{"date":43,"type":21},"2026-06-05",{"date":45,"type":21},"2034-06-05",{"name":47,"class":48},"Josep Rodes-Cabau","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"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,"INTERVENTIONAL",[61],"NA","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.",[64,65,66,67,68],"Patent Foramen Ovale","Cryptogenic Stroke","Older Patients","Medical Treatment","Recurrent Stroke","RECRUITING","2026-03-23",{"date":72,"type":41},"2026-03-27",{"date":74,"type":41},"2024-06-18",{"date":76,"type":21},"2037-10-01",{"name":47,"class":48},2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100459079","frailty-in-patient-undergoing-percutaneous-left-atrial-appendage-closure-100459079","NCT05257954","Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.","Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure The Frail-LAAC Study","Frail-LAAC","Inclusion Criteria:\n\n* Transcatheter LAAC with any approved device\n* Age ≥18 years old\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Severe neuropsychiatric impairment",{"count":88,"type":21},500,"To assess the prevalence and severity of frailty in patients undergoing LAAC, as well as its association to peri-procedural and long-term outcomes and quality of life.",[91,92],"Transcatheter Left Atrial Appendage Closure","Frailty",{"date":94,"type":41},"2026-03-24",{"date":96,"type":41},"2022-03-01",{"date":98,"type":21},"2029-03-01",{"name":47,"class":48},1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":59,"phases":113,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":100},"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,"60 Years",{"count":112,"type":21},100,[61],"To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.",[64,116,117],"Ischemic Stroke","Bleeding Ulcer",[119,116,120,121],"Transcatheter Patent Foramen Ovale (PFO) closure","Bleeding","Young patients",{"date":94,"type":41},{"date":124,"type":41},"2020-07-08",{"date":126,"type":21},"2032-08-01",{"name":47,"class":48},""]