[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-valve-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-valve-disease":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,52,77,100,128,149,175,198,224,251,273,296,332,358,381,405,433,456,478,512,533,555,583,602,628],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100614216","capture-2-controlled-arterial-protection-to-ultimately-remove-embolic-material-100614216",false,"NCT07276711","CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material","Controlled Arterial Protection to Ultimately Remove Embolic Material","Clinical Inclusion Criteria\n\n1. Age ≥ 22 years at the time of consent\n2. Meets FDA-approved indications for elective transfemoral self-expanding transcatheter aortic valve replacement (TAVR) procedure on a native or non-native (valve-in-valve) aortic valve. Note: Due to Neurologist availability and importance of capturing the neurological assessments, procedures must be performed Monday-Thursday.\n3. Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram\n4. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures\n5. Willing and able to comply with the protocol-specified procedures and assessments\n\nImaging Inclusion Criteria\n\n1. Echocardiogram including left ventricular ejection fraction ≥ 30% within 6 months (180 days) prior to the index procedure and prior to randomization to confirm adequate cardiac function.\n2. Subjects must undergo a computed tomography angiography (CTA) scan within 6 months (180 days) prior to the index procedure and prior to randomization to confirm anatomic compatibility with the study device and the control device. Subjects must meet the following anatomical inclusion criteria:\n\nEmStop Angiographic (CTA) Inclusion Criteria 1. Subject anatomy is compatible with correct device positioning with:\n\n* Ascending aorta length ≥8 cm\n* Femoral and iliac artery minimal lumen diameter of ≥ 8.0 mm\n* Ascending aorta\u002Faortic arch diameter is ≥25 or ≤40 mm.\n* Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification\n\nSentinel Angiographic (CTA) Inclusion Criteria\n\n1\\. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device positioning with:\n\n* Artery diameter is 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery\n* Arterial stenosis \\\u003C70% in either the left common carotid artery or the brachiocephalic artery\n* Brachiocephalic or left carotid artery without significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium\n* Adequate blood flow to the right upper extremity\n* Access vessels without excessive tortuosity\n\nExclusion Criteria:\n\n1. Requires use of a balloon-expandable transcatheter aortic valve for the index procedure\n2. Documented history of stroke or transient ischemic attack (TIA) within the prior 6 months, or any prior stroke with a permanent major disability or deficit (National Institute of Health Stroke Scale \\[NIHSS\\] \\>1 at baseline)\n3. Left ventricular ejection fraction \\\u003C30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure\n4. Acute myocardial infarction (MI) within 30 days of the planned index procedure\n5. Planned to undergo any other open cardiac surgical or left heart interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. The need for a postoperative pacemaker implant after TAVR is not exclusionary.\n6. Renal failure, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n7. Hypercoagulable state that cannot be corrected by additional periprocedural heparin\n8. History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated\n9. Undergoing therapeutic thrombolysis\n10. History of bleeding diathesis or major coagulopathy\n11. Hepatic failure (Child-Pugh class C)\n12. Active endocarditis or ongoing systemic infection, defined as fever (\\>38°C) and\u002For WBC \\>15,000 IU\n13. Known allergy to any materials used in the EmStop system (e.g., nitinol)\n14. Currently participating in another drug or device clinical study\n15. Known or suspected to be pregnant, or is lactating; women of child bearing age must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure\n16. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)\n17. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study","ALL","22 Years",{"count":20,"type":21},663,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus\u002Fdebris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.",[27,28,29],"Aortic Valve Stenosis","Aortic Stenosis","Aortic Valve Disease",[31,32,33,34,35,36,37,38],"Transcatheter aortic valve replacement (TAVR)","Cerebral embolic protection device","Stroke","Cerebrovascular accident","Neuroprotection","Aortic valve disease","Aortic valve stenosis","Aortic stenosis","RECRUITING","2026-06-24",{"date":42,"type":43},"2026-06-26","ACTUAL",{"date":45,"type":43},"2026-05-12",{"date":47,"type":21},"2028-05",{"name":49,"class":50},"EmStop Inc","INDUSTRY",3,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":63,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100602172","real-world-data-collection-on-the-inspiris-resilia-aortic-valve-100602172","NCT07120048","Real World Data Collection on the INSPIRIS RESILIA Aortic Valve","A Prospective, Observational Registry Study Designed to Collect Real-world Hemodynamic and Clinical Outcomes of the INSPIRIS RESILIA Aortic Valve","INDICATE","Inclusion Criteria:\n\n1. Patients requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose\n2. Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available\n3. Age ≥ 18 years\n4. Provision of written informed consent\n\nExclusion Criteria:\n\n1. Active endocarditis\u002Fmyocarditis or endocarditis\u002Fmyocarditis within 3 months prior to the scheduled aortic valve replacement surgery\n2. Emergency procedure\n3. Patients requiring a non-aortic heart valve procedure during the index procedure","18 Years",{"count":62,"type":21},500,"3 Months","OBSERVATIONAL","Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.",[29],"2026-06-18",{"date":69,"type":43},"2026-06-22",{"date":71,"type":43},"2025-07-30",{"date":73,"type":21},"2026-12",{"name":75,"class":50},"Edwards Lifesciences",14,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100639899","konect-resilia-aortic-valved-conduit-avc-real-world-study-assessing-safety-and-performance-100639899","NCT07619872","KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance","KONECTION","Inclusion Criteria:\n\n1. 18 years or older at the time of informed consent\n2. Have a diseased native or prosthetic aortic valve and a damaged or diseased ascending aorta that requires aortic valved conduit replacement surgery with the KONECT RESILIA AVC\n3. Provide written informed consent\n4. Willing to follow protocol requirements\n\nExclusion Criteria:\n\n1. Active endocarditis or endocarditis within 3 months prior to the study index procedure\n2. Emergency procedure\n3. Stage 4 renal disease (estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 excluded) or requiring dialysis\n4. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease in the opinion of the study investigator\n5. High predicted risk of mortality prior to the procedure: Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥8%",{"count":85,"type":21},250,"KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.",[29],[89],"Bentall","NOT_YET_RECRUITING","2026-05-26",{"date":93,"type":43},"2026-06-02",{"date":95,"type":21},"2026-06-30",{"date":97,"type":21},"2039-06-30",{"name":75,"class":50},1,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":99},"100538094","aortopathy-relationship-to-imagery-and-kinocardiography-features-artik-100538094","NCT06286358","Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)","Impact of Aortic Valve Disease and Thoracic Aortic Aneurysm on Kinocardiographic Signals","ARTIK","Inclusion Criteria\n\n* \"Interventional treatment\" group\n\n  * Adults (\\>18 y)\n  * Interventional treatment indication for severe AVD and\u002For severe TAA, as decided by the Heart Team\n* \"Aortic valve disease of different severities\" group\n\n  * Adults (\\>18y)\n  * Aortic stenosis and\u002For aortic regurgitation and\u002For bicuspidy of different severities confirmed by echocardiography and\u002For cardiac MRI\n* \"Control\" group : - Adults (\\>18 y) appariated with the participants of other groups according to their age, sex, body surface area and LVEF\n\nExclusion Criteria:\n\n* Any severe rhythm disorder such as frequent ventricular extrasystoles, atrial tachyarrhythmias\n* Subject's disabilty to give consent\n* Subjects suffering from aortic valve disease or thoracic aortic aneurysm will be excluded from the \"control\" group.",true,{"count":110,"type":21},180,"Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface.\n\nThe goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable to diagnose aortic valve disease and aortic aneurysm.\n\nIn patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and\u002For cardiac magnetic resonance imaging, KCG recordings, phonocardiography (PCG) recordings, and video recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG, PCG and video signal.",[29,113],"Aortic Aneurysm",[38,115,116,117],"Aortic regurgitation","Thoracic aortic aneurysm","Kinocardiography","2026-04-27",{"date":120,"type":43},"2026-05-01",{"date":122,"type":43},"2024-03-07",{"date":124,"type":21},"2026-12-30",{"name":126,"class":127},"Université Libre de Bruxelles","OTHER",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":99},"100543192","prospective-long-term-outcomes-of-a-standardized-ross-procedure-100543192","NCT06352671","Prospective Long-Term Outcomes of a Standardized Ross Procedure","ROSS","Inclusion Criteria:\n\n* Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Presence of active malignancy\n* Pregnant at the time of surgery\n* Inability to provide informed consent","90 Years",{"count":137,"type":21},225,"This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices\u002Ftechniques for stabilization of the autograft and right ventricular outflow tract reconstruction.",[29],"2026-04-13",{"date":142,"type":43},"2026-04-15",{"date":144,"type":43},"2023-10-12",{"date":146,"type":21},"2026-12-01",{"name":148,"class":127},"Baylor Research Institute",{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100632969","valvosoft-outcomes-registry-for-real-world-evidence-100632969","NCT07520591","Valvosoft Outcomes Registry for Real-World Evidence","Prospective Post-Market Clinical Follow-Up Registry to Assess the Long-term Safety and Effectiveness for the Treatment of Severe Symptomatic Aortic Valve Stenosis Using Valvosoft Non-Invasive Ultrasound Therapy","VALOR-PMCF","Inclusion Criteria:\n\n1. Suffering from calcific sSAS according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease.\n2. Not recommended by the local heart team for immediate TAVR\u002FSAVR, or refusing such an intervention.\n3. Willing to provide a written informed consent prior to participating in this Registry.\n4. Able to comply with the follow up schedule or other Study requirements.\n\nExclusion Criteria:\n\n1. Prosthetic aortic valve;\n2. Chest deformity preventing optimal contact between Patient's chest and Valvosoft Applicator;\n3. Thoracic injured skin, presence of scar(s) and\u002For burn(s) on thorax that may be in contact or close proximity with Valvosoft Applicator;\n4. Pregnant or breastfeeding Patient.",{"count":158,"type":21},200,"The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the Valvosoft® non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic calcific aortic stenosis (sSAS).\n\nValvosoft® delivers focused, high-intensity, short-duration ultrasound pulses to the aortic valve via a trans-thoracic approach, inducing non-thermal mechanical softening of calcified valve tissue.\n\nThis registry will enroll up to 200 participants across approximately 20 clinical sites in Europe following CE marking. Participants will be followed from discharge through 12 months post-procedure to assess clinical outcomes, quality of life, echocardiographic parameters, and safety events in a real-world setting.",[29,161,162,163,164],"Aortic Stenosis, Severe","Aortic Valve Calcification","Ultrasound Therapy","Heart Failure","2026-04-09",{"date":167,"type":43},"2026-04-14",{"date":169,"type":21},"2026-05-30",{"date":171,"type":21},"2028-06-30",{"name":173,"class":50},"Cardiawave SA",6,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":17,"minAge":183,"maxAge":135,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":99},"100428829","transcatheter-self-expandable-valve-implantation-for-the-treatment-of-severe-native-aortic-regurgitation-100428829","NCT04864145","Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation","Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation: a Prospective, Multicenter, Randomized Study","SEASON-AR","Inclusion Criteria:\n\n1. Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) \\> 65mm or left ventricular end-systolic dimension (LVESD) \\> 50mm;\n2. Severe aortic valve regurgitation, and mean pressure gradient \\\u003C 20mmHg; Annular perimeter ≤ 85 mm;\n3. The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;\n4. STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement:\n\n   1. Severe aorta calcification or active ascending aorta atherosclerotic plaque\n   2. History of mediastinum radiotherapy\n   3. Past mediastinitis\n   4. Presence of unobstructed coronary bypass implants\n   5. Previous more than two cardiothoracic surgeries\n   6. Liver cirrhosis\n   7. Other surgical risk factors\n\nExclusion Criteria:\n\n1. Age \\\u003C 60 years old;\n2. Ascending aorta diameter \\>45mm;\n3. Coronary multi-vessel disease (SYNTAX score \\>32);\n4. Life expectancy \\\u003C1 year;\n5. Left ventricular ejection fraction \\\u003C30%;\n6. Acute myocardial infarction within 30 days;\n7. Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents);\n8. Other situations judged by the researcher as unsuitable for participating in the study.","60 Years",{"count":185,"type":21},210,[24],"Prospective, multicenter, randomized trial.",[29],"2026-04-07",{"date":191,"type":43},"2026-04-08",{"date":193,"type":43},"2021-05-21",{"date":195,"type":21},"2031-05-30",{"name":197,"class":127},"Nanjing First Hospital, Nanjing Medical University",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":207,"conditions":208,"keywords":211,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":7},"100420397","valved-graft-pmcf-study-100420397","NCT04754217","Valved Graft PMCF Study","Valved Graft Post-Market Clinical Follow-up Study","Inclusion Criteria:\n\n* cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement\n\nExclusion Criteria:\n\n* anticoagulation therapy intolerant\n* active endocarditis\n* anatomical or medical, surgical, psychological or social contraindications",{"count":206,"type":21},260,"Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.",[29,209,210],"Ascending Aorta Abnormality","Aortic Dissection",[212,213,214,215,216],"Aortic Root Replacement","Ascending Aorta Replacement","Valved Graft","CAVGJ","VAVGJ",{"date":140,"type":43},{"date":219,"type":43},"2021-07-13",{"date":221,"type":21},"2029-09",{"name":223,"class":50},"Abbott Medical Devices",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100561787","the-jenavalve-align-ar-lvad-registry-100561787","NCT06594705","The JenaValve ALIGN-AR LVAD Registry","Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)","JENA-VAD","Inclusion Criteria:\n\n1. Subjects \\>=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3:\n\n   • AR is graded from 0 to 6 (0 = none; 1 = trace; 2 = mild; 3 = mild-to-moderate; 4 = moderate; 5 = moderate-to-severe; 6 = severe). Considering that AR during continuous flow LVAD (cfLVAD) support is generally both systolic and diastolic, AR is deemed significant if graded ≥ 3.1\n2. Patient with NYHA functional class III\u002FIV\n3. Patient with high risk for SAVR as documented by Heart Team.\n4. Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System\n5. Patient or the patient's legal representative has provided written informed consent\n6. Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Congenital uni- or bicuspid (Sievers 0) aortic valve morphology\n2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\n3. Mitral regurgitation \\> moderate\n4. Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure\n5. Echocardiographic or CT evidence of left ventricular or aortic valve thrombus\n6. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks\n7. Hypertrophic cardiomyopathy with or without obstruction\n8. Severe pulmonary hypertension (systolic PA pressure \\>80 mmHg)\n9. Decompensated right heart failure as assessed clinically and, if available, by baseline right heart catheterization hemodynamics (e.g., right atrial pressure \\> pulmonary capillary wedge pressure and cardiac index \\\u003C 2.5 L\u002Fmin\u002Fm2\n10. Severe RV dysfunction as assessed clinically and by echocardiography\n11. Aortic annular diameter of \\\u003C21.0 mm or \\> 28.6 mm (assessed by Multi-detector CT measurement)\n12. Aortic annulus angulation \\> 70° (assessed by Multi-detector CT measurement)\n13. Straight length of ascending aorta of \\\u003C 55 mm\n14. Significant disease of ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \\[\\>5 mm\\], protruding or ulcerated)\n15. Myocardial infarction \\\u003C 30 days prior to index procedure\n16. Cerebrovascular event (TIA, stroke) \\\u003C 180 days prior to index procedure\n17. Blood dyscrasias as defined: leukopenia (WBC \\\u003C 3000\u002Fmm³), or thrombocytopenia (platelets \\\u003C 90,000\u002Fμl) or anemia (Men: Hgb \\\u003C 8.1 g\u002Fdl; Women: Hgb \\\u003C 7.4 g\u002Fdl)\n18. Active peptic ulcer or upper gastrointestinal bleeding \\\u003C 90 days prior to index procedure\n19. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated\n20. Subject unable to undergo pre-procedure transesophageal echocardiography or Multi-Detector CT (MDCT) scan for aortic annular sizing\n21. Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this registry)",{"count":233,"type":21},50,[24],"To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR",[237,238,239,29,240],"Aortic Regurgitation","Aortic Valve Insufficiency","Aortic Insufficiency","Left Ventricular Dysfunction","2026-03-30",{"date":243,"type":43},"2026-04-01",{"date":245,"type":43},"2024-12-09",{"date":247,"type":21},"2027-08",{"name":249,"class":50},"JenaValve Technology, Inc.",15,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":108,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":99},"100220916","ambulatory-electrocardiographic-monitoring-for-the-detection-of-high-degree-atrio-ventricular-block-in-patients-with-new-onset-persistent-left-bundle-branch-block-after-transcatheter-aortic-valve-implantation-the-mare-study-100220916","NCT02153307","Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The \"MARE\" Study","MARE","Inclusion Criteria:\n\n-Patients undergoing TAVI with either balloon or self-expandable valves who develop new-onset LBBB persistent at hospital discharge, at least 3 days after the procedure\n\nExclusion Criteria:\n\n* Failure to provide informed consent\n* Baseline pacemaker\u002Fdefibrillator or pacemaker\u002Fdefibrillator implanted during the hospitalization period following the TAVI procedure\n* Pre-existing complete LBBB\n* Patients with a life-expectancy of less than 2 years",{"count":259,"type":21},80,[24],"The purpose of this study is to determine the incidence and predictors of high degree or complete atrioventricular block (AVB) (paroxysmal or persistent) in patients with new-onset persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve implantation (TAVI) and to evaluate the usefulness of the Reveal LINQ® insertable Cardiac Monitor (ICM) (Medtronic, Inc., Minneapolis, USA) for the detection of significant arrhythmias in patients with NOP-LBBB following TAVI.",[29,263],"Conduction Disturbances","2026-03-23",{"date":266,"type":43},"2026-03-24",{"date":268,"type":4},"2014-01",{"date":270,"type":21},"2026-07",{"name":272,"class":127},"Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":281,"maxAge":4,"enrollmentInfo":282,"targetDuration":63,"studyType":64,"phases":4,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":99},"100621134","savvywire-for-pacing-and-procedural-hemodynamics-in-transcatheter-aortic-valve-replacement-evaluation-100621134","NCT07366671","SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation","SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation; a Prospective Registry (SAPPHIRE)","SAPPHIRE","Inclusion Criteria:\n\n* Age ≥ 50 years\n* Accepted for transfemoral TAVI procedure by Heart team and TAVI team\n* Transfemoral TAVI procedure with balloon-expandable or self-expandable TAVI platform\n* Ability to understand and the willingness to provide written informed consent\n* Patients scheduled for valve-in-valve procedures can be included\n* Patients with bicuspid anatomy can be included\n\nExclusion Criteria:\n\n* Patients planned for a non-transfemoral TAVI procedure\n* Extremely horizontal aorta (aortic root angle \\>70 degrees)\n* Extreme tortuosity at the level of the iliofemoral arteries, abdominal and\u002For thoracic aorta\n* Inability to provide informed consent.","50 Years",{"count":283,"type":21},300,"The goal of this observational study is to document which LV-guidewires are used during a TAVI (Transcatheter Aortic Valve Implantation) procedure and how their different functions perform.\n\nA TAVI procedure is a minimally invasive treatment for aortic stenosis, where a new heart valve is inserted through a blood vessel in the groin. During this procedure, a wire (specifically, an LV-guidewire) is used to place the new heart valve. For this purpose, a regular LV-guidewire or a newer LV-guidewire with extra features, the Savvywire, can be used. All of these wires work well, are safe, and are already used in daily medical practice. Researchers will compare these LV-guidewires to see if the Savvywire adds additional value.\n\nPatients aged 50 or older who undergo a TAVI procedure via the femoral artery (blood vessel in the groin) can participate. Participants will receive the usual care and standard follow-up, only their data will be collected and analyzed.",[286,29],"TAVI(Transcatheter Aortic Valve Implantation)","2026-03-10",{"date":289,"type":43},"2026-03-11",{"date":291,"type":43},"2026-01-12",{"date":293,"type":21},"2028-03",{"name":295,"class":127},"dr Pim A.L. Tonino",{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":306,"conditions":307,"keywords":320,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":250},"100613478","cohort-observing-mechanisms-progression-and-sequelae-of-valvular-heart-disease-100613478","NCT07267117","Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease","Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease (VALVE-COMPASS)","VALVE-COMPASS","Inclusion Criteria:\n\n* At least 18 years old;\n* Be willing and able to provide informed consent to participate in the study;\n* Patients with heart valve disease diagnosed by echocardiography who meet one of the following criteria:\n\n  1. Grade II or higher Aortic valve regurgitation: regurgitant jet width \\>3 mm, jet width \u002F LVOT diameter ≥25%, jet cross-sectional area\u002FLVOT cross-sectional area ≥5%, effective regurgitant orifice area (EROA) ≥0.1 cm², regurgitant volume per beat (R Vol)≥30 ml, or regurgitant fraction (RF) ≥30%.\n  2. Moderate or higher aortic valve stenosis: peak velocity ≥3.0 m\u002Fs, Mean gradient ≥20 mm Hg, aortic valve area ≤1.5 cm², Indexed aortic valve area ≤0.85 cm²\u002Fm², or velocity ratio ≤0.50.\n  3. Grade II or higher mitral valve regurgitation: regurgitant jet width ≥3 mm, regurgitant volume per beat ≥30 ml, regurgitant jet area\u002Fleft atrial area \\>30%, or effective regurgitant orifice area (EROA) ≥0.2 cm².\n  4. Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg.\n  5. Grade II or higher tricuspid valve regurgitation: regurgitant jet width ≥3 mm, proximal isovelocity surface area ≥6 mm, effective regurgitant orifice area (EROA) ≥0.2 cm², or regurgitant volume per beat ≥30 ml.\n  6. Significant tricuspid valve stenosis: mean pressure gradient ≥5.0 mmHg, inflow time-velocity integral \\>60 cm, T1\u002F2 ≥190 ms, or valve area ≤1.0 cm².\n  7. Grade II or higher pulmonary valve regurgitation: regurgitant jet width \\>3 mm, regurgitant volume per beat ≥30 ml, regurgitant fraction ≥30%, or effective regurgitant orifice area (EROA) ≥0.1 cm².\n  8. Moderate or higher Pulmonary valve stenosis: pulmonary valve transvalvular pressure gradient ≥40 mmHg, right ventricular systolic pressure ≥60 mmHg, or pulmonary valve opening \\\u003C1.5 cm².\n\nExclusion Criteria:\n\n* Patients who are unwilling to accept registration and follow-up;\n* Patients who cannot cooperate with information collection and follow-up due to mental illness or other conditions;\n* Patients whose life expectancy is less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease, or end-stage lung disease).",{"count":305,"type":21},10000,"The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.",[308,309,310,311,29,27,312,313,314,315,316,317,318,319],"Heart Valve Disease","Mitral Valve (MV) Regurgitation","Mitral Valve Disease","Mitral Valve Stenosis","Tricuspid Valve Disease","Tricuspid Valve Regurgitation","Aortic Valve Regurgitation","Pulmonary Valve Disease","Transcatheter Valve Replacement","Transcatheter Aortic Valve Replacement (TAVR)","Transcatheter Pulmonary Valve Replacement (TPVR)","Transcatheter Edge-to-edge Repair",[321,322],"Heart Valve Disease Progression","Heart Valve disease sequelae","2025-11-25",{"date":325,"type":43},"2025-12-05",{"date":327,"type":43},"2025-06-01",{"date":329,"type":21},"2030-05-31",{"name":331,"class":127},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":99},"100593628","cardioheartconnect-commercially-available-fitness-for-cardiac-rehabilitation-100593628","NCT07008911","CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation","CardioHeartConnect: Commercially Available Fitness mHealth for Cardiac Rehabilitation Among Individuals Recovering From Transcatheter Aortic Valve Replacement","Inclusion Criteria:\n\n* Appropriate for cardiac rehabilitation (CR) referral, as determined by the UCHealth Structural Heart \\& Valve Clinic team\n* Community-dwelling\n* Reside in the United States\n* Able to speak and understand English\n* Able to provide informed consent\n* Able to stand with or without an assistive device\n* Able to see and hear content on the Peloton App via phone, tablet, or computer\n\nExclusion Criteria:\n\n\\- Determined to be inappropriate for cardiac rehabilitation referral by the UCHealth Structural Heart and Valve Clinic team",{"count":158,"type":21},[24],"This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules, compared to educational control among patients recovering from transcatheter aortic valve replacement (TAVR). The study aims to improve physical activity, functional capacity, quality of life, and cardiovascular health using wearable devices and a digital engagement platform. A total of 200 patients will be recruited from the UCHealth Structural Heart and Valve Clinic and randomized to either CardioHeartConnect or CardioHeartEd. Participants will be assessed at baseline, 8 weeks, and 12 months using surveys, smartwatch data, and electronic health records.",[27,29],[344,345,346,347,348],"Cardiac Rehabilitation","Transcatheter Aortic Valve Replacement","TAVR","Mobile Health","Peloton","2025-08-27",{"date":351,"type":43},"2025-08-28",{"date":353,"type":21},"2025-09-30",{"date":355,"type":21},"2029-08-01",{"name":357,"class":127},"University of Colorado, Denver",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":365,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":4},"100599924","streamlined-one-wire-logistics-optimize-transcatheter-aortic-valve-replacement-100599924","NCT07090811","Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement","SOLO-TAVR","Inclusion Criteria:\n\n1. Scheduled for a THV or BAV procedure in accordance with standard institutional protocols requiring temporary pacing.\n2. Willing and able to comply with the follow-up evaluations\n3. Been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)\n\nExclusion Criteria:\n\n1. Undergoing an emergent procedure\n2. An ST elevation myocardial infarction (STEMI) within 7 days of procedure\n3. Had cardiac arrest within 7 days of procedure requiring CPR or defibrillation\n4. An indication to require mechanical cardiac support (MCS) post-procedure\n5. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical circulatory support within 30 days prior to index procedure\n6. Active endocarditis within 30 days prior to index procedure\n7. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation\n8. Severe aortic annular or sub annular calcium per operator evaluation.\n9. Bicuspid aortic valve stenosis WITH severe raphe calcium per operator evaluation.\n10. Had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 90 days of index procedure\n11. Severe peripheral vascular disease that would preclude safe placement of an introducer sheath\n12. A planned alternative (i.e., non-femoral) access site\n13. A comorbidity that would preclude index procedure or use of the Solo Pace Fusion System\n14. A known, untreated neurological, psychological, psychiatric or other disorder that would interfere with trial endpoints or with cooperation with the requirements of the trial\n15. Participating in another investigational drug or device study\n16. Pregnant, lactating, or plan to become pregnant during the study (women of child-bearing potential must have a pregnancy test).","21 Years","85 Years",{"count":368,"type":21},20,[24],"The goal of this study is to determine the safety and performance of a new guidewire and pacing system called the Fusion System in treating patients undergoing transcatheter aortic valve replacement (TAVR) or similar procedures. The main questions it aims to answer are:\n\nIs the Fusion System safe? Is the Fusion System's clinical performance acceptable?\n\nParticipants will asked to sign a study consent and report any adverse events experienced until they are discharged from hospital (or a maximum of 2 days following their procedure).",[29],"2025-07-31",{"date":374,"type":43},"2025-08-05",{"date":376,"type":21},"2025-09",{"date":378,"type":21},"2026-04",{"name":380,"class":50},"Solo Pace, Inc.",{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":389,"targetDuration":391,"studyType":64,"phases":4,"briefSummary":392,"conditions":393,"keywords":394,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":99},"100594604","a-clinical-and-imaging-registry-of-transcatheter-aortic-valve-implantation-using-jenavalve-system-j-valve-system-for-patients-with-pure-aortic-regurgitation-100594604","NCT07021612","A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System\u002F J-Valve System for Patients With Pure Aortic Regurgitation","A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System\u002F J-Valve System for Patients With Pure Aortic Regurgitation: An Observational Study","CAIR-JAR","Inclusion Criteria:\n\n1. receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve\u002FJ-Valve) in PWH\n2. with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy\n3. Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)\n4. Capable of providing informed consent\n\nExclusion Criteria:\n\n1. Evidence of intracardiac mass, thrombus or vegetation\n2. Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT\n3. Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure\n4. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.\n5. Chronic Kidney Disease with eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2.\n6. Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device\n7. Contraindicated for CT or MRI assessment",{"count":390,"type":21},30,"1 Year","Aortic regurgitation (AR) is not uncommon. Transcatheter aortic valve implantation (TAVI) for treating pure aortic regurgitation is a potential future treatment option for pure AR especially in patients having high risk for open heart surgery.\n\nTAVI using dedicated device for pure AR has a different anchor mechanism to TAVI for aortic stenosis (AS). AR patientsalso have different cardiac flow pattern, aortic root pathology and left ventricular remodeling pattern compared to AS patients. Subclinical leaflet thrombosis has been described in AS patient receiving TAVI, which will affect the durability and antithrombotic regime. Follow-up imaging for dedicated TAVI device in AR patient is limited.",[29],[395],"Transcatherter Aortic Valve Intervention","2025-06-13",{"date":398,"type":43},"2025-06-15",{"date":400,"type":43},"2025-04-01",{"date":402,"type":21},"2028-09-30",{"name":404,"class":127},"Prince of Wales Hospital, Shatin, Hong Kong",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":417,"conditions":418,"keywords":419,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":429,"leadSponsor":431,"locationsCount":99},"100492077","phase-3-direct-oral-anticoagulation-and-bioprothesis-aortic-valve-100492077","NCT05687448","DIrect Oral Anticoagulation and Bioprothesis Aortic Valve","DIrect Oral Anticoagulant for Antithrombotic Management Of Aortic Bioprothesis Valve implaNted Patients for Valvular Heart Disease Study","DIAMOND","Inclusion Criteria:\n\n1. Male or female ≥18 years of age\n2. Prior implantation of a surgical bioprosthesis in the aortic position at least 7 days and before hospital discharge (excluding TAVI)\n3. Participants currently not requiring chronic anticoagulation for another reason (atrial fibrillation, pulmonary embolism or any other condition)\n4. Patients affiliated to social security\n5. Patient able to give free, informed and written consent\n\nExclusion Criteria:\n\n1. Any cardiac surgery less than 7 days prior to enrollment or more than 1 month\n2. Mechanical valve in any position or combined valve surgery (mitral or tricuspid).\n3. Any major bleeding in the three months (90 days) prior to enrollment.\n4. Active bleeding or high risk of bleeding after cardiac surgery (i.e. hemopericardium) or lesion or condition considered as a significant risk factor for major bleeding according to investigator\n5. Atrial fibrillation requiring chronic anticoagulation\n6. Need to be on dual antiplatelet therapy (aspirin \\>100 mg daily and a P2Y12 inhibitor, i.e. clopidogrel, ticagrelor, prasugrel) or requiring chronic anticoagulation whatever the treatment (oral or injection).\n7. Known hypersensitivity or other contraindications to apixaban (hepatic disease associated with coagulopathy and clinically relevant bleeding risk).\n8. Creatinine clearance \\\u003C40 mL\u002Fmin (Cockcroft) or patients requiring apixaban dose reduction.\n9. Known hypersensitivity or other contraindications to aspirin (Hypersensitivity to aspirin or any of the excipients, history of asthma induced by the administration of salicylates, ongoing peptic ulcer, constitutional or acquired hemorrhagic disease including gastrointestinal bleeding, history of hemorrhagic stroke and thrombocytopenia, pregnancy after 24 weeks of gestation, risk of bleeding, severe renal failure, severe hepatic impairment, uncontrolled severe heart failure\n10. Known hypersensitivity or other contraindications to heparin or low molecular weight heparin (history of heparin-induced thrombocytopenia, hypersensitivity to any of the excipients…)\n11. Ischemic stroke within 1 month or intracranial hemorrhage\n12. Active endocarditis at the time of screening for enrollment.\n13. Women of childbearing potential without efficient contraception, pregnant or breastfeeding women.\n14. Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.\n15. History of non-compliance\n16. Participation in another interventional study\n17. Active cancer or life expectancy less than 1 year\n18. Persons deprived of their liberty by judicial or administrative decision",{"count":414,"type":21},1500,[416],"PHASE3","DIAMOND study is a national, multicentre, randomized, parallel-group, open label study in patients (aged ≥18 years) with aortic bioprosthesis (excluding TAVI) at least 7 days after cardiac surgery.\n\nExperimental group:\n\nPatients treated with apixaban 5 mg twice daily (BID)\n\nActive Comparator group:\n\nAspirin 75 to 100mg once a day\n\nThe primary objective is to demonstrate that antithrombotic treatment with apixaban is superior to aspirin in patients with recent surgical bioprosthetic aortic valve replacement for the primary composite efficacy endpoint of death from any cause, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis after 105 days of follow-up.",[29],[420,421,422,423,33,424],"Anticoagulant","Aortic valve","Apixaban","Aspirin","Hemorrhage","2025-06-09",{"date":427,"type":43},"2025-06-12",{"date":376,"type":21},{"date":430,"type":21},"2029-03",{"name":432,"class":127},"Assistance Publique - Hôpitaux de Paris",{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":108,"sex":17,"minAge":439,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":99},"100593020","scapis-2-cardio---vibrometer-based-pulse-wave-analysis-and-cvd-risk-assessment-100593020","NCT07001007","SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment","Inclusion Criteria:\n\n* Subjects already included in the main \u002F general SCAPIS 2 study at Danderyd Hospital in Stockholm, and of which has also participated in the echocardiography examination\n\nExclusion Criteria:\n\n* Patients unable to provide an informed consent","58 Years","72 Years",{"count":442,"type":21},1600,"This clinical investigation will evaluate a novel contactless technology for assessing arterial stiffness and pulse wave characteristics and explore its potential in assessment of coronary artery disease, aortic stenosis and heart failure, in a population-based sample aged 58-72 years.\n\nIt will be the first in clinical setting, pilot stage, observational investigation to evaluate the clinical safety, performance and diagnostic accuracy of Cardio P4, a laser-doppler vibrometry (LDV) and microwave radar-based device.",[445,446,29,164],"Coronary Arterial Disease (CAD)","Arterial Stiffness","2025-05-30",{"date":449,"type":43},"2025-06-03",{"date":451,"type":43},"2024-07-01",{"date":453,"type":21},"2026-06",{"name":455,"class":50},"HJN Sverige AB\u002FNeko Health",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":99},"100488062","dexamethasone-olanzapine-hemodynamics-and-ventilation-in-cardiac-surgery-100488062","NCT05635227","Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery","Dexamethasone, Olanzapine, Flow-targeted Versus Pressure-targeted Hemodynamic Management, and Low Tidal Volume Ventilation in Patients Undergoing On-pump Cardiac Surgery - a Multifactorial Design Randomized Trial","GLORIOUS-II","Inclusion Criteria:\n\n1. Adult, i.e., above 18 years of age\n2. Scheduled for CABG and\u002For AVR, irrespective of other concomitant valve surgery.\n\nExclusion Criteria:\n\n1. Acute surgery (i.e. off hours surgery)\n2. Pregnancy or currently breastfeeding. Pregnancy in all fertile women will be ruled out by pregnancy testing prior to randomization.\n3. Known endocarditis at time of screening\n4. Previous participation in the trial\n5. Active infection, including bacterial, viral, and\u002For fungal infection\n6. Known hepatic cirrhosis\n7. Known severe thrombocytopenia with thrombocyte levels \\\u003C 50 x 109\u002FL\n8. Known severe neutropenia with neutrocyte levels \\\u003C 2 x 109\u002FL\n9. On the waiting list for a heart transplant\n10. Recipient of any major organ transplant\n11. Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism\n12. Having received cytotoxic\u002Fcytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months.\n13. Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer.\n14. Known narrow-angle glaucoma\n15. Known phenylketonuria\n16. Type I diabetes\n17. Known long QT syndrome\n18. Known allergy for any of the included study drugs\n19. Any condition, where participation in the study, in the investigator's opinion could put the subject at risk, confound the study results or interfere significantly with participation in the study\n\nPatients with extracardiac arteriopathy (assessed as part of the pre-operative EuroSCORE) will be excluded from the intervention 'flow-targeted vs. pressure-targeted hemodynamic management during CPB'.",{"count":465,"type":21},1200,[24],"Open heart surgery, including coronary artery bypass grafting (CABG) and\u002For aortic valve replacement (AVR) is associated with a significant risk of mortality.\n\nThis study is a randomized clinical trial with the purpose of investigating four different interventions on the primary endpoint 'days alive and outside of hospital within 90 days'.\n\nThe interventions are:\n\n* Dexamethasone vs. placebo administered after induction of anesthesia.\n* Olanzapine vs. placebo administered prior to anesthesia.\n* A blood-flow targeted vs. a blod-pressure targeted hemodynamic strategy while the patient is on cardio-pulmonary bypass (CPB)\n* Low-tidal volume ventilation vs. no ventilation of the lungs while the patient is on CPB",[469,29],"Coronary Artery Disease",{"date":471,"type":43},"2025-04-04",{"date":473,"type":43},"2022-11-10",{"date":475,"type":21},"2028-02",{"name":477,"class":127},"Rigshospitalet, Denmark",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":496,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":99},"100584966","tavr-the-impact-of-prothesis-positioning-on-valvular-and-coronary-hemodynamics-100584966","NCT06896227","TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics","Transcatheter Aortic Valve Implantation (TAVR): The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics","Inclusion Criteria\n\n\\- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).\n\nExclusion Criteria\n\n* Any access route other than transfemoral.\n* Valve-in-valve procedures.\n* History of prior bioprosthetic valve implantation.\n* Presence of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) system.\n* Diagnosis of liver cirrhosis.\n* Esophageal disorders, including but not limited to esophageal varices.\n* Thrombocytopenia or coagulation disorders.\n* Any medical or psychiatric condition (e.g., dementia, alcoholism, or substance abuse) that may impair the ability to provide informed consent or interfere with study procedures, including follow-up visits.",{"count":486,"type":21},100,[24],"The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries.\n\nThe main questions it aims to answer are:\n\n1. Does the cardiac magnetic resonance imaging and the echocardiography imaging provide an equivalent alternative to the computer tomography which is the state of the art in evaluating commissural alignment?\n2. What effect does the position of the valve on the annular level have, especially its symmetrical and commissural position, on valvular and aortic blood flow characteristics?\n3. What is the influence of symmetrical position and the presence of a commissural alignment on the coronary flow after transcatheter aortic valve replacement?",[345,490,491,492,493,494,495,27,29],"Transcatheter Aortic Valve Implantation","Commissural Alignment","Commissural Misalignment","Symmetry","Prothesis Positioning","Prosthesis Durability",[346,497,498,493,499,500,501,502],"TAVI","Commissural alignment","Prothesis positioning","cMRI","4D Flow","TEE","2025-03-19",{"date":505,"type":43},"2025-03-26",{"date":507,"type":43},"2024-10-22",{"date":509,"type":21},"2025-12-31",{"name":511,"class":127},"Heinrich-Heine University, Duesseldorf",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100572783","clinical-trial-evaluating-the-safety-and-efficacy-of-artificial-polymer-heart-valve-for-the-treatment-of-aortic-valve-disease-100572783","NCT06737757","Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease","Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease","Inclusion Criteria:\n\n1. The subjects are aged ≥18 years old;\n2. The subjects understand the nature and purpose of the study, voluntarily participate, and sign the informed consent form. They agree to comply with the trial requirements, cooperate with surgical treatment and follow-up, and consent to relevant follow-up inquiries and examinations;\n3. The subjects have been confirmed to have severe aortic valve stenosis and\u002For regurgitation (also known as insufficiency) through echocardiography;\n4. According to the 2020 ACC\u002FAHA guidelines for the management of patients with valvular heart disease, the subjects meet the indications for surgical aortic valve replacement and preoperative assessment recommends surgical aortic valve replacement.\n\nExclusion Criteria:\n\n1. Other valve diseases with surgical indications, such as severe mitral regurgitation, severe tricuspid regurgitation, moderate or greater mitral stenosis, or a history of previous aortic or other valve replacement surgery;\n2. Other severe cardiovascular conditions with surgical indications, such as Stanford A-type aortic dissection, aortic sinus aneurysm (sinus diameter \\> 5.0cm), hypertrophic obstructive cardiomyopathy, diffuse three-vessel coronary artery disease, or placement of a left ventricular assist device in end-stage heart failure;\n3. End-stage heart failure that is not reversible even with aortic valve surgery, such as severe left ventricular dysfunction (LVEF \\\u003C 25%), or severe heart failure that cannot be corrected, or severe pulmonary hypertension assessed by right heart catheterization, with planned postoperative Impella, IABP, or left ventricular assist;\n4. Preoperative decompensated heart failure, cardiogenic shock, malignant arrhythmias, etc., requiring mechanical circulatory support, mechanical ventilation, or emergency surgery;\n5. Active endocarditis within the past 3 months or the presence of cardiac vegetations;\n6. Severe acute myocardial infarction or history of cerebrovascular accidents within the past 3 months (excluding lacunar infarcts);\n7. Severe renal insufficiency (glomerular filtration rate \\\u003C 30mL\u002Fmin) or end-stage renal disease requiring long-term dialysis;\n8. Liver dysfunction or gastrointestinal malnutrition-related diseases;\n9. Active bleeding, bleeding tendencies, or patients unable to receive anticoagulant therapy;\n10. Severe respiratory or ventilatory dysfunction requiring continuous oxygen therapy;\n11. Poor compliance or cognitive impairment (such as coma, Parkinson's disease, dementia, substance abuse), inability to follow study requirements or refusal to participate in follow-up visits;\n12. Other conditions with an expected lifespan of less than 1 year, such as malignancies and immunodeficiency diseases;\n13. Other situations not suitable for artificial aortic valve replacement or participation in this trial.",{"count":520,"type":21},198,[24],"The purpose of this study is to conduct the clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance. This prospective, multicenter, randomized controlled, non inferiority clinical trial is expected to enroll 198 subjects and conduct a 1:1 random grouping. The experimental group will use polymer material surgical aortic valves（PoliaVavle, HeartHill Medical, Suzhou China) for aortic valve replacement, while the control group will use bovine pericardial biological valves for aortic valve replacement.",[27,29,314],"2024-12-23",{"date":526,"type":43},"2024-12-30",{"date":528,"type":21},"2024-12",{"date":530,"type":21},"2029-12",{"name":532,"class":50},"Suzhou Hearthill Medical Technology Co.,LTD",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":545,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":552,"locationsCount":554},"100530683","rapid-atrial-pacing-after-tavi-to-predict-pacemaker-implantation-100530683","NCT06189976","Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation","Rapid Atrial Pacing After TAVI as a Predictor of Permanent Pacemaker Implantation","Inclusion Criteria:\n\n1. Adults ≥18 years old.\n2. Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.\n3. Patient has given written consent to participate in the trial.\n4. Patients undergoing TAVI as a treatment of severe aortic stenosis (AS).\n5. Patient in sinus rhythm.\n6. Patients planned for TAVI with utilization of temporary pacemaker electrode placement.\n\nExclusion Criteria:\n\n1. Ongoing infection, including active endocarditis.\n2. Implanted permanent pacemaker and\u002For implantable cardioverter\u002Fdefibrillator.\n3. Patients developing persistent second or third degree atrioventricular block (AV) after TAVI.\n4. Underlying rhythm other than sinus based on the surface ECG leads monitoring after TAVI.\n5. Patients with second or third degree AV block identifyied on the screening pre-TAVI ECG.\n6. Enrolment in another study that competes or interferes with this study.\n7. Subject will not be able to comply with the follow-up requirements according to investigators' opinion.\n8. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study.",{"count":541,"type":21},400,[24],"Despite Transcatheter aortic valve implantation (TAVI) evolution regarding techniques, equipment and experience, the need for permanent pacemaker implantation (PPI) post-TAVI remains an important drawback. The electrophysiology testing to stratify the risk or necessity of PPI post-TAVI is endorsed by the up-to-date guidelines and consensus documents and it is a valuable cut-off based method. Part of the answer is maybe hidden in the easy and applicable testing of the atrioventricular conduction system through rapid atrial pacing (RAP) with a common temporary pacemaker lead. This trial is designed to investigate the role and value of RAP after TAVI as a predictor of the necessity of new PPI.",[29,490,497],[346,497,546,38],"Rapid atrial pacing",{"date":548,"type":43},"2024-12-12",{"date":550,"type":43},"2024-03-01",{"date":509,"type":21},{"name":553,"class":127},"National and Kapodistrian University of Athens",2,{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":565,"conditions":566,"keywords":569,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":579,"leadSponsor":581,"locationsCount":99},"100395582","immune-responsiveness-and-outcome-after-aortic-valve-surgery-measure-100395582","NCT04430972","Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)","Is Pre-operative Impaired imMune rEsponsiveness Associated With Adverse Outcome Following Aortic Valve Replacement SURgEry (MEASURE)","Measure","Inclusion Criteria:\n\n• Patients undergoing first-time open aortic valve replacement surgery\n\nExclusion Criteria:\n\n* Age less than 18y (capacity to consent)\n* Ongoing sepsis (immunomodulatory effects, established influence on outcome from surgery)\n* Immunosuppressive therapy\n* Suffering from known immunosuppressive disease\n* Pregnancy (immunosuppressive aspects to pregnancy)",{"count":564,"type":21},150,"There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are exposed during surgery.\n\nThe investigators have previously demonstrated that having higher pre-operative antibody levels is associated with a lower risk of infection and a shorter stay in hospital after cardiac surgery.\n\nThe investigators aim to study 150 patients undergoing aortic valve replacement and explore their dynamic immune responsiveness. The investigators will determine if this response is correlated with the post-operative outcome (development of post-operative infection or increased length of hospital stay).\n\nThe investigators will compare this response with the previously measured static markers of immune competence and also with a novel device that may give a more rapid measure of dynamic immunity.\n\nThe investigators will approach patients in the cardiac surgical pre-assessment clinic to see if they are willing to participate in the study.\n\nImmediately once under anaesthetic blood will be taken for testing and then again at the end of surgery, 24h after surgery, at discharge from hospital, and at follow-up clinic approximately 4 weeks later. There will be no additional needle insertions on top of those routinely performed. The investigators will collect data from the routine observations as far as 1 year after surgery.\n\nIf the investigators can show an association between immune function and subsequent post-operative outcome it may be possible to determine ways to improve outcomes for patients undergoing heart surgery.\n\nThis might include better information on risks and benefits of surgery, actively boosting immune function (vaccination, immune-nutrition), passively improving immunity (administering antibodies), or consider current alternatives to open heart surgery where the threat of infection or inflammation may be markedly reduced (eg trans-catheter aortic valve implantation)",[29,567,568],"Surgery--Complications","Immune System Disorder",[570,571,572,573,574],"staphylococcus","EndoCAb","Immunity","Cardiac Surgical Procedure","sepsis","2024-11-15",{"date":577,"type":43},"2024-11-18",{"date":376,"type":21},{"date":580,"type":21},"2026-09",{"name":582,"class":127},"Barts & The London NHS Trust",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":590,"targetDuration":592,"studyType":64,"phases":4,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":99},"100473051","tavr-for-aortic-valve-disease-100473051","NCT05439863","TAVR for Aortic Valve Disease","Transcatheter Aortic Valve Replacement for Severe Aortic Valve Disease: Multi-center, Real-word Registry","Inclusion Criteria:\n\n1. Clinical diagnosis of severe aortic stenosis or aortic regurgitation\n2. Patients undergo transcatheter aortic valve replacement\n\nExclusion Criteria:\n\npatients refuse the clinical follow-up",{"count":591,"type":21},5000,"15 Years","Transcatheter aortic valve replacement (TAVR) has became an important treatment of severe aortic stenosis (AS). Several randomized clinical trials showed that TAVR was non-inferior or superior to surgical aortic valve replacement (SAVR). However, many different issues have emerged: TAVR in younger patients? valve leaflet thrombosis? transcatheter valve durability? coronary reaccess after TAVR? TAVR in bicuspid aortic valve? TAVR in aortic regurgitation? etc. Hence, a prospective, multicenter database is created to provide the real-word data for these questions.",[29],"2024-11-13",{"date":575,"type":43},{"date":598,"type":43},"2022-07-01",{"date":600,"type":21},"2037-12-30",{"name":197,"class":127},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":610,"enrollmentInfo":611,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":612,"conditions":613,"keywords":614,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":99},"100518023","the-study-on-the-use-of-uniline-bioprosthesis-in-the-treatment-of-isolated-aortic-and-mitral-valve-diseases-100518023","NCT06025149","The Study on the Use of \"UniLine\" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases","Open, Prospective, Multicenter Study of the Safety and Efficacy of \"UniLine\" Epoxy-treated Prosthesis Made From Xenopericardium in the Treatment of Isolated Aortic and Mitral Valve Diseases","Uniline","Inclusion Criteria:\n\n1. Provided informed consent to participate in the study.\n2. Must be aged 18 years and older.\n3. Patients with isolated acquired mitral or aortic valve disease.\n4. No prior heart valve replacement, current replacement must be planned (not conducted in an urgent\u002F emergency manner), using the \"UniLine\" biological prosthesis made from xenopericardium.\n5. Patient must be able to visit the Research Center.\n\nExclusion Criteria:\n\n1. Mechanical or biological prosthesis in another position. Patients with tricuspid valve repair may be included in the study.\n2. Prior heart valve replacement.\n3. Concomitant interventions on the heart (coronary artery bypass grafting, coronary heart disease treatment, surgical reconstruction of a left ventricular aneurysm) and thoracic aorta.\n4. Patients with cancer in history.\n5. Patients with musculoskeletal conditions with severe movement disorders and diseases of the central nervous system, accompanied by cognitive disorders (disorientation, inability to independently reach the destination).\n6. Acute or subacute stages of infective endocarditis.\n7. Class IV heart failure according to the New York Heart Association Functional Classification with ongoing therapy, left ventricular ejection fraction less than 40%, myocardial infarction less than 90 days old, angina pectoris grade 4.\n8. The presence of severe somatic, neurological, mental and infectious diseases that worsen the prognosis of long-term survival: tuberculosis, human immunodeficiency virus, Alzheimer's disease, epilepsy, chronic kidney disease stage 3b (Glomerular Filtration Rate less than 30 mL\u002F min \u002F 1.73 m²), chronic lung diseases requiring constant intake of corticosteroids and bronchodilators, multifocal atherosclerosis (grade 3 chronic lower limb ischemia, stenosis of the carotid arteries more than 50%, prior and planned interventions on the abdominal aorta, carotid arteries or arteries of the lower extremities).","80 Years",{"count":283,"type":21},"The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic\u002Fmitral valve replacement using the \"UniLine\" bioprosthesis in patients with acquired aortic or mitral valve diseases.\n\nMain research objectives:\n\nTo analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the \"UniLine\" bioprosthesis.\n\nTo study the hemodynamic characteristics of normally functioning \"UniLine \" prostheses in the mitral or aortic valve position based on the transthoracic echocardiography data.\n\nTo assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the results of their treatment.\n\nTo analyze the frequency of major serious adverse events associated with the \"UniLine\" bioprosthesis or procedure.",[29,310],[615,616,617,618],"UniLine biological prosthesis","Acquired valve disease","Acquired aortic valve disease","Acquired mitral valve disease","2024-09-24",{"date":621,"type":43},"2024-09-25",{"date":623,"type":43},"2018-09-01",{"date":625,"type":21},"2035-01-31",{"name":627,"class":127},"Closed Joint-Stock Company NeoCor",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":183,"maxAge":636,"enrollmentInfo":637,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":639,"conditions":640,"keywords":642,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":664,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":99},"100515990","post-market-clinical-monitoring-of-the-safety-and-efficacy-of-the-aortic-valve-bioprothesis-100515990","NCT05998694","Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis","Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis \"ТiAra\" (T-ara)","TiAra","Inclusion Criteria:\n\n1. The patient's written consent to participate in the study and the absence of restrictions on physical movement (diseases of the musculoskeletal system and diseases of the central nervous system, accompanied by cognitive disorders (disorientation, inability to independently reach the destination).\n2. The patient is a resident of the city\\* (suburb) where the institution is conducting study.\n\n   \\* - participation is also possible for those living in the rural areas, but they have to be able to make visits to the Research Center.\n3. Age: 60-70 years old with a life expectancy of 3 years or more. Or a person younger than 60 with contraindications to taking anticoagulants, or with increased risk of their use, consciously choosing a biological prosthesis for valve replacement.\n4. Isolated aortic valve disease.\n5. Real intervention on the heart valve is primary.\n6. Absence of concomitant interventions on the heart and thoracic aorta\\*\\*.\n\n   \\*\\* - Coronary artery bypass grafting, correction of tricuspid valve disease, previously treated congenital heart defects, aortic intervention\n7. The intervention on the valve is planned (that is, it is not carried out in expedited\u002Furgent manner or is not a \"rescue\" operation).\n8. Absence of acute and subacute infective endocarditis.\n9. The following factors should not be present before surgery: high pulmonary hypertension (pulmonary arterial systolic pressure more than 60 mmHg), functional class 4 (according to the New York Heart Association Functional Classification) while in ongoing treatment, left ventricular ejection fraction less than 30%.\n\nExclusion Criteria:\n\n1. The presence of severe somatic, neurological, mental diseases and infectious diseases that worsen the prognosis of long-term survival (ischemic heart disease, tuberculosis, human immunodeficiency viruses, Alzheimer's disease, epilepsy, insulin-requiring diabetes, kidney disease with creatinine clearance less than 85 mL\u002Fmin, chronic lung disease requiring chronic corticosteroids and bronchodilators, multifocal atherosclerosis (intermittent claudication, carotid arteries stenosis of more than 50%, prior and planned interventions on abdominal area, carotid arteries or arteries of the lower extremities).\n2. The patient has any not related to the underlying cardiovascular system disease pathology that will lead to the death of the patient in less than 1 year.\n3. The patient is currently participating in a study of a new drug or other medical devices.","70 Years",{"count":638,"type":21},2000,"The goal of this multicenter prospective cohort study is to evaluate the long-term safety and efficacy of clinical outcomes of aortic valve replacement using the \"TiAra\" prosthesis with or without concomitant procedures.\n\nMain research objectives:\n\n1. To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the \"TiAra\" prosthesis.\n2. To study the hemodynamic characteristics of normally functioning \"TiAra\" prostheses in the aortic position, as well as the condition of the heart chambers in short and long-term period (up to 10 years) after the implantation.\n3. To assess complications of the early and mid-term follow-up periods of aortic valve replacement using the \"TiAra\" prosthesis.\n\nThis study does not presuppose implementation of comparison groups.",[29,641],"Artificial Heart Valves",[643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663],"aortic valve","aortic valve bioprothesis TiAra","valve bioprosthesis","hemolysis","hemolytic anemia","a heart stroke","myocardial infarction","hemorrhaging and bleeding","heart arrhythmia","nonstructural dysfunction","pannus","prosthesis-patient mismatch","dislocation","paraprosthetic and transprosthetic regurgitation","heart failure","breast-pang","structural deterioration","valve thrombosis","thromboembolism","encarditis","a reoperation",{"date":621,"type":43},{"date":666,"type":43},"2021-06-01",{"date":668,"type":21},"2026-08-10",{"name":627,"class":127}]