[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitraclip\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitraclip":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100609357","enhanced-valves-interventions-and-safe-ai-generated-end-results-100609357",false,"NCT07213531","Enhanced Valves Interventions and Safe AI Generated End Results","ENVISAGE","Inclusion Criteria:\n\nPatients who have reached the age of legal majority under local laws.\n\n* For TAVI group: All patients who have had TAVI with a third generation transcatheter heart valve (THV), with an available pre-procedural optimal quality CT scan as defined by an ECG- gating CT with:\n\n  1. five to ten image volumes at cardiac phases from 5% to 95% R-R\n  2. 0.625 mm slice thickness\n  3. 0.625 mm spacing between slices\n  4. 0.88 mm in-plane pixel spacing\n* For TMVI group: Patients who have had a TMVI with a dedicated device and screen failures, with an available optimal quality CT scan.\n* For TTVI group: Patients who have had a TTVI with a dedicated device and screen failures, with an available optimal quality CT scan.\n* For M-TEER: All patient who have had a M-TEER with 1) G4 or newer iteration of MitraClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos images from one of two vendors: Phillips or GE, with clear identifiable views of the Mitral valve, frame per second equal or higher than 40 frames per second, acceptable 3D reconstructions.\n* For T-TEER: All patient who have had a T-TEER with G4 or newer iteration of TriClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos images from one of two vendors: Phillips or GE, with clear identifiable views of the Tricuspid valve, frame per second equal or higher than 40 frames per second, acceptable transgastric image with acceptable 3D reconstructions.\n\nExclusion Criteria:\n\n* For TAVI group: Valve-in-valve procedures\n* For TMVI group: Valve-in-valve and valve-in-ring procedures\n* For TTVI: Valve-in-valve and valve-in-ring procedures\n* For M-TEER: G3 or older MitraClip, G1 Pascal\n* For T-TEER: G3 Triclip, G1 Pascal","ALL","18 Years",{"count":19,"type":20},21000,"ESTIMATED","OBSERVATIONAL","This non-interventional study aims to use artificial intelligence to improve the prediction of transcatheter heart valve interventions and optimize patient outcomes. It is based on the analysis of retrospective data from various specialized centers worldwide.",[24,25,26,27,28,29,30,31],"Heart Valve Disease","TAVI","M-TEER","TTVI","TMVI","T-TEER","Mitraclip","TriClip",[33,34,35,26,29,25,28,36,37],"Medical imaging","CT","Artificial intelligence","valvulopathy","predictive algorithms","RECRUITING","2025-10-01",{"date":41,"type":42},"2025-10-09","ACTUAL",{"date":44,"type":42},"2024-05-01",{"date":46,"type":20},"2029-05",{"name":48,"class":49},"Montreal Heart Institute","OTHER",15,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":74,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100567356","optimization-of-heart-failure-hf-medical-therapy-after-transcatheter-valve-intervention-tvi-in-patients-with-heart-failure-with-reduced-ejection-fraction-hfref-100567356","NCT06667128","Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)","OPTIMAV","Inclusion Criteria:\n\n* Hospital admission for severe symptomatic valve disease (aortic stenosis, mitral regurgitation, or tricuspid regurgitation) effectively treated with transcatheter valve intervention (TVI) during hospitalization.\n* Chronic heart failure with reduced ejection fraction (HFrEF)\n* At the time of randomization (1-2 days prior to discharge):\n\n  1. NT-proBNP \\> 900 pg\u002FmL.\n  2. Systolic blood pressure ≥ 100 mmHg.\n  3. Heart rate ≥ 60 bpm.\n  4. Serum potassium ≤ 5.0 mEq\u002FL (mmol\u002FL).\n* At the time of hospital admission treated with ≤ ½ of the of optimal dose of ACEi\u002FARB\u002FARNi, ≤ ½ of the of optimal dose of beta-blocker, and ≤ ½ of the of optimal dose of MRA, either with or without SGLT2ic.\n* Residency in the Lombardy region.\n* Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 or \\> 85 years.\n* Clearly documented intolerance to ACEi\u002FARB\u002FARNI, or beta-blockers, or MRA, or SGLT2i.\n* Residual severe valve disease of the valve treated with TVI (i.e. severe aortic stenosis or severe paravalvular leak after TAVR, severe mitral stenosis or severe residual mitral regurgitation after mitral valve intervention, or severe tricuspid stenosis or severe residual tricuspid regurgitation after tricuspid valve intervention).\n* Presence at the time of randomization (1-2 days prior to discharge) of any severe valve disease.\n* Hemodynamically significant obstructive lesion of the left ventricular outflow tract.\n* Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\\\u003C 1 liter or need for chronic systemic or non-systemic steroid therapy, or any kind of primary right HF such as primary pulmonary hypertension or recurrent pulmonary embolism.\n* Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy device implantation within 3 months, or percutaneous transluminal coronary intervention, within 1 month prior to screening.\n* Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.\n* History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.\n* Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.\n* Active infection at any time during hospitalization requiring intravenous antibiotics.\n* Stroke or TIA within 3 months prior to screening.\n* Primary liver disease considered to be life threatening.\n* Renal disease or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 (as estimated by the simplified MDRD formula) at screening or history of dialysis.\n* Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \\\u003C12 months.\n* Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening.\n* Discharge to a rehabilitation of long-term care facility.\n* Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and\u002For comply with the protocol instructions or follow-up procedures\n* Pregnant or nursing (lactating) women.","85 Years",{"count":60,"type":20},160,"INTERVENTIONAL",[63],"NA","This trial is a single-center, open-label, randomized study designed to assess the impact of a rapid up-titration of Guideline-Directed Medical Therapy (GDMT) on heart failure with reduced ejection fraction (HFrEF) patients following transcatheter valve interventions. The study focuses on the efficacy of intensive treatment in decreasing NT-proBNP levels and improving patient outcomes, including survival rates and quality of life over a six-month period. Patients are closely monitored using both Point-of-Care technology and hospital-based assessments, with the goal of enhancing GDMT adjustments. This approach is compared to standard care to determine its potential benefits in the management of HFrEF post-valve intervention.",[66,67,68,69,70,71,72,30,73],"Heart Failure","Valvulopathy","Aortic Stenosis","Aortic Regurgitation Disease","Mitral Regurgitation","Tricuspid Regurgitation","Brain Natriuretic Peptide","TAVI(Transcatheter Aortic Valve Implantation)",[66,68,75,70,71,30,76,25],"Aortic Regurgitation","Triclip","NOT_YET_RECRUITING","2024-10-31",{"date":80,"type":42},"2024-11-04",{"date":82,"type":20},"2025-02-01",{"date":84,"type":20},"2026-02-01",{"name":86,"class":49},"IRCCS Ospedale San Raffaele",1]