[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"valve-disease-aortic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:valve-disease-aortic":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,80,106],{"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":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100608144","delineate-prospective-100608144",false,"NCT07197736","DELINEATE-Prospective","Deep Learning for Echo Analysis, Tracking, and Evaluation Prospective Evaluation (DELINEATE-Prospective)","DELINEATE","Inclusion Criteria:\n\n* Attending cardiologist employed by Columbia University, ColumbiaDoctors, or NewYork Presbyterian Hospital who reads transthoracic echocardiograms in the Columbia echocardiography laboratory\n* Provided informed consent to take part in the questionnaires or pivotal study\n\nExclusion Criteria:\n\n* Physician in training (cardiology fellow or advanced imaging fellow)","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","OBSERVATIONAL","Heart disease is the leading cause of death in the United States, and echocardiography (or \"echo\") is the most common way doctors look at the heart. Echo is safe, painless, and can detect major heart problems, including weak heart pumping and valve disease.\n\nValve disease, especially aortic stenosis (narrowing) and mitral regurgitation (leakage), is common in older adults but often goes undiagnosed. While echo is the main tool for finding valve problems, it takes time, requires expert training, and results can vary between readers.\n\nRecent advances in artificial intelligence (AI), especially deep learning (DL), have shown promise in automatically analyzing heart images. However, past research hasn't fully tackled key echo techniques-like color Doppler and spectral Doppler-that are crucial for measuring how blood moves through heart valves. AI tools also face challenges in being used in everyday medical practice because of workflow issues, lack of real-world testing, and concerns about how the algorithms make decisions.\n\nAt Columbia University Irving Medical Center, researchers have built a large database of heart tests over the last six years and developed AI programs to analyze echocardiograms. The current study will test whether providing AI analysis to cardiologists in real time during echo reading can make the process faster and more consistent.",[25,26,27,28,29,30],"Valve Disease, Aortic","Mitral Regurgitation (MR)","Aortic Stenosis","Valvular Heart Disease","Tricuspid Regurgitation (TR)","Aortic Regurgitation",[32,33,34,35,36,37,38],"artificial intelligence","deep learning","valvular heart disease","echocardiography","cardiovascular disease","mitral regurgitation","aortic stenosis","RECRUITING","2026-04-14",{"date":42,"type":43},"2026-04-16","ACTUAL",{"date":45,"type":21},"2026-04-15",{"date":47,"type":21},"2028-10-01",{"name":49,"class":50},"Columbia University","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":51},"100633277","self-expanding-hydra-transcatheter-heart-valve-thv-series-versus-balloon-expandable-devices-for-valve-in-valve-transcatheter-aortic-valve-implantation-tavi-for-patients-with-failed-surgical-aortic-bioprosthesis-100633277","NCT07524595","Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.","Randomised Comparison of Self-Expanding Hydra THV Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis: REVIVAL Trial","REVIVAL","\"Inclusion Criteria\":\n\n1. Male or Female patient ≥18 years of age\n2. Severe hemodynamic valve deterioration of a surgically implanted bioprosthetic aortic valve, including severe valve stenosis and\u002For severe valve regurgitation, as determined by the Heart Team assessment\n3. Patients eligible for transfemoral TAVI with both study THV platforms per heart team consensus.\n4. TAVI (with or without fracture of surgical valve) is suitable with commercially available sizes of both Hydra and Sapien\u002FMyvall BEVs.\n5. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee and is willing to comply with all protocol-required (follow-up) evaluations.\n\n\"Exclusion criteria\":\n\n1. Patients unwilling to provide an informed consent, or whose legal representative object to their participation in the study\n2. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in woman of child-bearing potential according to local practice)\n3. Patients with non-transfemoral TAVI access.\n4. Surgical or transcatheter valve in mitral position (mitral rings are not an exclusion)\n5. Patients who had received the Bentall procedure.\n6. Patients with active bacterial endocarditis or ongoing sepsis ≤6 months prior to the index procedure\n7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n8. Acute myocardial infarction ≤30 days before the intended TAVI procedure\n9. Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated\n10. Patients with severe left ventricular dysfunction and ejection fraction \\\u003C30% or hemodynamic instability requiring inotropic agent or mechanical support.\n11. Patients with significant renal insufficiency (serum creatinine \\>3.0 mg\u002FdL (265.5μmol\u002FL)) and\u002For end stage renal disease requiring chronic dialysis\n12. Patients who are at very high risk of coronary obstruction (e.g., VIVID classification IIB, IIIB, IIIC) and are judged by the heart team to require upfront leaflet laceration (e.g. Basilica or Unicorn procedure) or chimney or snorkel stenting as part of the TAVI procedure.\n13. Any planned surgical or peripheral procedure to be performed in next 30-day after the index procedure\n14. Life expectancy \\\u003C12 months due to non-cardiac co-morbid conditions including carcinomas, chronic liver disease, chronic renal disease or chronic end-stage pulmonary disease",{"count":61,"type":21},111,"INTERVENTIONAL",[64],"NA","This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic bioprosthesis. A total of 111 patients will be randomized in a 2:1 ratio, with 74 patients assigned to self-expanding Hydra THV Series and 37 patients assigned to BEV (Sapien THV Series and MyVal THV Series).",[67,68,69,25],"AORTIC VALVE DISEASES","Valve-in-valve Procedures","Surgical Valve Replacement","NOT_YET_RECRUITING","2026-04-05",{"date":73,"type":43},"2026-04-13",{"date":75,"type":21},"2026-04",{"date":77,"type":21},"2027-08",{"name":79,"class":50},"National University of Ireland, Galway, Ireland",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":62,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":51},"100617565","arcflex-sheath-in-tavr-trial-100617565","NCT07320274","ArcFlex Sheath in TAVR Trial","ArcFlex Sheath in TAVR Trial(Arc-FIT)","Arc-FIT","Inclusion Criteria:\n\n* Judged by a professional cardiologist to require TAVR surgery\n* NYHA ≥ II grade\n* Evaluated by the cardiac team, the peripheral vascular approach is suitable for performing the surgery via the femoral route\n* Expected lifespan is greater than 1 year (5) Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-ups.\n\nExclusion Criteria:\n\n* Presence of other valvular diseases requiring concurrent intervention.\n* Anatomical characteristics unsuitable for transcatheter valve implantation.\n* Severe mitral stenosis due to organic causes requiring surgical valve replacement or repair.\n* Hypertrophic obstructive cardiomyopathy (unexplained myocardial hypertrophy \\>1.5 cm).\n* Acute myocardial infarction within the past 30 days.\n* Intracardiac mass, thrombus, or vegetation indicated by echocardiography.\n* Active infective endocarditis or any other active infection.\n* Intolerance to tolerate anticoagulant or antiplatelet therapy.\n* Coagulopathy or refusal to receive blood transfusion therapy.\n* Known allergy to device materials or contrast agents.\n* Acute peptic ulcer or gastrointestinal bleeding within the past 3 months.\n* Stroke or transient ischemic attack (TIA) within the past 3 months.\n* Requirement for emergency surgical treatment for any reason.\n* Expected life expectancy of less than 12 months due to non-cardiac causes.\n* Severe disabling dementia or inability to perform activities of daily living.\n* Participation in other clinical trials of drugs or medical devices prior to enrollment and not yet reached the primary endpoint of that study.",{"count":89,"type":21},180,[64],"TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.",[25],[94,95,96],"TAVR","Sheath","ArcFlex","2025-12-21",{"date":99,"type":43},"2026-01-06",{"date":101,"type":21},"2026-03-01",{"date":103,"type":21},"2030-03-30",{"name":105,"class":50},"Sun Yat-sen University",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":62,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":51},"100545863","allogeneic-valve-transplantation-100545863","NCT06387446","Allogeneic Valve Transplantation","Inclusion Criteria\n\n* Patients requiring aortic, pulmonary, mitral or tricuspid valve replacement.\n* Pediatric patients 30 days or older and \\\u003C 18 years, and adult patients 18-50 yrs.\n\n  o Particularly patients with significant growth potential\n* Insufficient options are available for valve replacement\n\n  o Patients at risk of immunogenic bio-prosthetic valve failure\n* Discussion with patient \u002Ffamily - option for durable valve rather than traditional prosthesis\n* ABO compatible\n* Patient and family able to travel to BCH within 48 hour time frame or within our organ procurement organization\n* Patients that are able to maintain follow-up at BCH during the duration of the study\n* Patients that are able to provide medical record authorization for 5 year follow-up\n\nExclusion Criteria\n\n* Age \\\u003C 30 days\n* Irreversible multisystem organ failure; or additive effects of the multiple systems affected making transplant survival unlikely\n* Progressive systemic disease with early mortality (genetic\u002Fmetabolic, idiopathic, syndromic)\n* Morbid obesity (BMI\\>35)\n* Diabetes mellitus with evidence of end-organ damage\n* Severe chromosomal, neurologic or syndromic abnormalities\n* Immunocompromised condition (DiGeorge, SCID etc.)\n* Active infection\n* History of endocarditis\n* HIV or chronic hepatitis B or C infection\n* Malignancy within 5 years prior to transplant\n* Severe renal or liver failure\n* Inadequate social support for post-transplant management\n* Recent history of illicit drug, tobacco or alcohol abuse despite trials\u002Fassistance to stop behavior\n* Evidence of large stroke with high risk for hemorrhagic conversion\n* Heart transplant recipient\n* Patients that are unable to follow-up during the initial 6 month window\n* Patients that are unable to provide medical record authorization for 5 years","30 Days","50 Years",{"count":5,"type":21},[64],"Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.",[118,119,25],"Valve Heart Disease","Valve Disease, Heart","2024-09-22",{"date":122,"type":43},"2024-09-24",{"date":124,"type":43},"2024-05-01",{"date":126,"type":21},"2027-06-01",{"name":128,"class":50},"Boston Children's Hospital"]