[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-regurgitation-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-regurgitation-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,40,68,94,118,147,184,204,235],{"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":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100644850","aspirin-monotherapy-versus-sequential-warfarin-aspirin-therapy-after-tavr-in-patients-with-pure-aortic-regurgitation-100644850",false,"NCT07677410","Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation","Prospective, Multicenter, Randomized Controlled Trial Evaluating the Safety and Efficacy of Different Antithrombotic Therapy Strategies in Patients With Severe Aortic Regurgitation Undergoing Transcatheter Aortic Valve Replacement","AWATAR","Inclusion Criteria:\n\n* Age ≥18 years.\n* Patients with severe aortic regurgitation (AR) who achieve technical success after TAVR using devices specifically indicated for AR (per VARC-3 criteria).\n* Trileaflet aortic valve anatomy.\n* No long-term anticoagulation indication (including but not limited to: atrial fibrillation, mechanical mitral valve prosthesis, deep vein thrombosis, pulmonary embolism, left ventricular thrombus, pulmonary hypertension, or coagulation disorders) as confirmed by the investigator.\n* Signed written informed consent and willingness to comply with randomization, study procedures, and follow-up.\n\nExclusion Criteria:\n\n* Need for oral anticoagulation or dual antiplatelet therapy, or need for oral or intravenous strong CYP3A inhibitors that cannot be paused during the study period.\n* Active pathological bleeding, subdural hematoma, or history of intracranial hemorrhage.\n* Ischemic stroke within 30 days before TAVR.\n* Acute myocardial infarction within 30 days.\n* Severe hepatic insufficiency (cirrhosis, hepatic decompensation).\n* Severe renal insufficiency (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or need for renal replacement therapy.\n* Stent implantation (including coronary, carotid, or peripheral arteries) within 12 months before TAVR, or planned stent implantation within 1 year after TAVR.\n* Coronary artery bypass grafting (CABG) within 12 months before TAVR.\n* Allergy, intolerance, or known resistance to aspirin, clopidogrel, or warfarin.\n* Known coagulation disorders or bleeding diathesis (including but not limited to platelet count ≤50,000\u002Fmm³ at screening).\n* Any contraindication to anticoagulation therapy.\n* Prior aortic valve prosthesis (mechanical or bioprosthetic); mitral valve bioprosthesis replacement within 1 year before TAVR; or prior mitral mechanical valve replacement; or prior tricuspid valve replacement.\n* Emergency TAVR with cardiogenic shock manifesting as low cardiac output, vasopressor or respiratory dependence, or mechanical hemodynamic support.\n* Life expectancy \\\u003C1 year (e.g., terminal malignancy).\n* Participation in another investigational drug or device clinical study (patients who have completed the primary endpoint of the study and are currently in long-term follow-up are not excluded).\n* Pregnancy or planned pregnancy, or use of estrogen or estrogen-like drugs (for women with suspected pregnancy, serum or urine human chorionic gonadotropin test must be negative before enrollment).\n* Any other condition deemed by the investigator to be inappropriate for study participation.","ALL","18 Years",{"count":20,"type":21},1172,"ESTIMATED","INTERVENTIONAL",[24],"NA","This multicenter randomized controlled trial evaluates antithrombotic strategies post-TAVR in severe aortic regurgitation patients without long-term anticoagulation. Patients are randomized 1:1 to aspirin 75-100 mg daily for 12 months versus warfarin (INR 2-3) for 6 months followed by aspirin for 6 months. Primary hypothesis: aspirin is superior for bleeding and non-inferior for death\u002Fthrombosis. Primary endpoint is a composite of death, stroke, thrombosis, MI, embolism, and major bleeding at 1 year. Sample size: 1172. Follow-up: 30 days, 6 months, 12 months.",[27],"Aortic Regurgitation Disease","NOT_YET_RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":31,"type":21},{"date":35,"type":21},"2030-07-01",{"name":37,"class":38},"Shanghai Zhongshan Hospital","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":52,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":39},"100630330","artificial-intelligence-in-aortic-regurgitation-100630330","NCT07486271","Artificial Intelligence in Aortic Regurgitation","Artificial Intelligence in Aortic Regurgitation: A Multicenter Randomised Controlled Trial","Inclusion Criteria:\n\n* Confirmed AR diagnosis via TTE and Doppler imaging per guidelines.\n* Age ≥ 18 years.\n* Adequate acoustic window for AR quantification.\n\nExclusion Criteria:\n\n* Prior cardiac transplant or implanted cardiac devices.\n* Poor image quality.\n* Pregnancy or lactation.",{"count":48,"type":21},540,[24],"This research project aims to develop and validate a tool that uses artificial intelligence (AI) to automatically detect and quantify aortic regurgitation (AR). The clinical efficacy of this tool will be established by comparing it to manual diagnostic methods in a multicenter randomized controlled trial. By leveraging deep learning (DL) techniques, the AI system will automate aortic regurgitation (AR) detection, measurement, and diagnosis, addressing challenges like variability in echocardiographic interpretations and the need for specialized expertise. It will integrate multiple echocardiographic parameters to provide accurate, standardized, and efficient AR diagnoses, reducing human error and improving consistency. This tool will enhance diagnostic precision and accessibility, improving clinical outcomes and extending advanced diagnostic capabilities to a broader range of healthcare environments, including resource-limited settings.",[27],[53,54,55,56,57],"Aortic Regurgitation","Artificial Intelligence","Echocardiography","Automated Diagnosis","Clinical Efficacy","RECRUITING","2026-03-17",{"date":61,"type":32},"2026-03-20",{"date":63,"type":32},"2025-12-01",{"date":65,"type":21},"2028-03-31",{"name":67,"class":38},"Chinese University of Hong Kong",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":17,"minAge":18,"maxAge":76,"enrollmentInfo":77,"targetDuration":79,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":39},"100619900","noninvasive-real-time-arterial-waveform-monitoring-for-cardiovascular-disease-assessment-100619900","NCT07350629","Noninvasive Real-Time Arterial Waveform Monitoring for Cardiovascular Disease Assessment","A Study on Noninvasive Real-Time Arterial Pressure Waveform Analysis for the Detection and Evaluation of Cardiovascular Diseases","Inclusion Criteria:\n\n* Age 18-80 years\n* Able to provide informed consent\n* For AR group: clinically diagnosed aortic regurgitation\n* For AS group: clinically diagnosed aortic stenosis\n* For healthy controls: no history of cardiovascular disease\n* Able to undergo finger arterial waveform measurement\n\nExclusion Criteria:\n\n* History of recent cardiac surgery or intervention (\\\u003C6 months)\n* Hand disorders affecting finger mobility (e.g., arthritis)\n* Pregnant or breastfeeding women\n* Participation in other studies affecting arterial waveform\n* Unable to understand or comply with study procedures",true,"80 Years",{"count":78,"type":21},15,"1 Day","OBSERVATIONAL","The goal of this observational study is to learn whether noninvasive real-time arterial waveform monitoring can be used to assess cardiovascular diseases in adults. The main question it aims to answer is:\n\nCan photoacoustic imaging accurately capture arterial waveforms from patients' fingers? Can features extracted from the arterial waveforms reflect the type and severity of cardiovascular diseases? Participants will be asked to place their fingers into the imaging device, where their finger arterial pulse information will be noninvasively recorded.",[27,83,84],"Aortic Stenosis Disease","Healthy Subjects","2026-01-11",{"date":87,"type":32},"2026-01-20",{"date":89,"type":32},"2025-12-26",{"date":91,"type":21},"2026-02",{"name":93,"class":38},"Anhui Provincial Cancer Hospital",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":39},"100598774","the-artemis-data-collection-study-100598774","NCT07075861","The ARTEMIS Data Collection Study","JenaValve Trilogy for Patients With Pure Native Aortic Valve Rigurgitation: the ARTEMIS Data Collection Study","ARTEMIS","Inclusion Criteria:\n\n* Considered at high or prohibitive risk for surgical aortic valve replacement by the Heart Team\n\n  * 18 years of age or older\n  * Suitable anatomy according to the IFU\n  * Absence of significant disease of the ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50mm or greater) or atheroma (especially if thick \\[\\>5mm\\], protruding or ulcerated)\n\nExclusion Criteria:\n\nThe JenaValve Trilogy Heart Valve System is contraindicated for use in patients who have known hypersensitivity or contraindication to Nitinol (titanium and\u002For nickel), an anti-coagulation\u002Fanti-platelet regimen or contrast medium that cannot be managed with premedication, or who have active bacterial endocarditis or other active infections.\n\nThe JenaValve Trilogy Heart Valve System is contraindicated in those patients whose anatomy does not accommodate the System due to anatomical considerations outlined in the inclusion criteria.",{"count":103,"type":21},75,"To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection",[27],[107,53,108],"JenaValve Trilogy","TAVI","2025-12-17",{"date":111,"type":32},"2025-12-24",{"date":113,"type":32},"2025-08-10",{"date":115,"type":21},"2028-08-10",{"name":117,"class":38},"IRCCS Policlinico S. Donato",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100582948","towards-a-more-standardized-bicuspid-aortic-valve-repair-rationale-and-design-of-contour-trial---a-randomized-trial-100582948","NCT06869954","Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial - a Randomized Trial","Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial","CONTOUR","Inclusion Criteria:\n\n1. Presence of fused BAV phenotype with an asymmetric configuration (commissural orientation \\\u003C 170 degree) \\[14\\]\n2. Severe aortic regurgitation (vena contracta (vc) \\> 6mm and\u002For pressure half-time (PHT) \\\u003C 200 ms and\u002For effective regurgitant orifice area (EROA) \\> 30 mm2 and\u002For regurgitant volume (RV) \\> 60 ml\u002Fbeat and\u002For left ventricular end-systolic diameter (LVESD) \\> 50mm (or indexed LVESD \\> 20mm\u002Fm2 BSA) and\u002For regurgitation fraction (RF) in cardiothoracic MRI \\> 40%) (at least one parameter is required) \\[15\\]\n3. Isolated aortic valve surgery or concomitant procedure (including CABG and\u002For mitral\u002Ftricuspid valve surgery and\u002For ascending aortic surgery)\n4. Willingness to participate and written informed consent\n5. Age at surgery \\> 18 years\n\nExclusion Criteria:\n\n1. Moderate\u002Fsevere BAV stenosis (pmean \\> 20mmHg)\n2. Moderate\u002Fsevere BAV cusp calcifications extending beyond the raphe region and\u002For necessitating patch implantation (deemed irreparable based on preoperative TOE (as by decision of the operating surgeon)\n3. Concomitant aortic root aneurysm \\> 45mm requiring simultaneous aortic root surgery \\[16\\]\n4. Acute\u002Fsubacute BAV endocarditis\n5. Contraindication to MRI",{"count":127,"type":21},100,[24],"Background: Between one-third and one-half of patients with bicuspid aortic valve (BAV) disease develop significant aortic regurgitation (AR) at a young age, leading to cardiomyopathy and heart failure. Aortic valve repair is an evolving and still underused strategy in BAV patients with AR. The lack of sufficient standardization remains the main limitation of current repair techniques, resulting in an increased risk of AR recurrence and reoperation. The most controversial issue is the stabilization of the BAV annulus. The CONTOUR trial aims to compare two different BAV annuloplasty concepts in a prospective randomized study.\n\nMethods: CONTOUR is a multicenter, randomized controlled trial designed to enroll 100 consecutive BAV patients with AR across four sites in Germany. BAV AR patients with an asymmetric configuration and without concomitant root aneurysm will be randomized 1:1 to undergo aortic valve repair using an internal HAART 200 annuloplasty device (i.e., INTERNAL group) (n=50) or external annuloplasty (i.e., double external ring annuloplasty) in the EXTERNAL group (n=50). 4D flow MRI will be performed preoperatively (t1), postoperatively at discharge (t2), and at 1-year follow-up (t3) for rater-blinded assessment of hemodynamic profiles (i.e., flow eccentricity) and regurgitation fraction at the MRI core-lab. Two hierarchically ordered primary endpoints will be considered: (1) postoperative reduction of flow eccentricity at hospital discharge and (2) regurgitation fraction (%) at 1-year follow-up.\n\nDiscussion: The CONTOUR trial is designed to test the hypothesis that an internal annuloplasty device, creating a completely symmetric post-repair BAV geometry, achieves superior aortic valve repair outcomes compared to external annuloplasty. If our hypothesis is confirmed, our study will significantly influence aortic valve repair practice and contribute to the refinement of guideline recommendations in the management of BAV patients with AR.",[131,27],"Bicuspid Aortic Valve (BAV)",[133,134,135,136],"aortic regurgitation","aortic valve repair","annuloplasty","bicuspid aortic valve","2025-10-01",{"date":139,"type":32},"2025-10-07",{"date":141,"type":32},"2025-05-21",{"date":143,"type":21},"2027-06",{"name":145,"class":38},"University Hospital Augsburg",4,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":160,"conditions":161,"keywords":166,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":39},"100600620","phase-4-effect-of-losartan-on-the-neurohumoral-axis-and-ventricular-remodeling-of-patients-with-severe-aortic-regurgitation-undergoing-valve-surgery-100600620","NCT07099859","Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery.","Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery","ARBNP","Inclusion criteria:\n\n* Age ≥ 18 years;\n* Postoperative period of aortic valve replacement surgery due to severe aortic regurgitation of any etiology;\n* Signed Informed Consent Form.\n\nExclusion Criteria:\n\nTo avoid potential bias in data interpretation, the following patients will be excluded:\n\n* Those who underwent cardiac surgery in the context of cardiogenic shock or infective endocarditis;\n* Patients with ischemic cardiomyopathy;\n* Patients with other significant concomitant valvular diseases.\n\nPatients with conditions where losartan use may be harmful will also be excluded, including:\n\n* Chronic kidney disease with an estimated glomerular filtration rate (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m²);\n* Systolic blood pressure (SBP) \\\u003C 90 mmHg at the time of randomization;\n* Elevated serum potassium (K \\> 5.5 mEq\u002FL) at the time of randomization;\n* Pregnancy;\n* Known intolerance or allergy to losartan.","85 Years",{"count":157,"type":21},60,[159],"PHASE4","Why Is This Study Important? The heart has valves that help control blood flow. Aortic regurgitation (AR) is a condition where one of these valves (the aortic valve) doesn't close properly, causing blood to leak back into the heart. Over time, this makes the heart work harder and grow larger (remodeling) to keep up. Many patients with severe AR need valve replacement surgery to fix this problem.\n\nAfter surgery, the heart doesn't have to work as hard, and over time, it can shrink back to a healthier size (reverse remodeling). However, doctors don't know if medications can help speed up or improve this healing process. This study aims to find out if a common blood pressure medication, losartan, can help the heart recover better after surgery.\n\nWhat Do the Investigators Already Know? Doctors often prescribe medications like ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and spironolactone to people with heart failure because these drugs help the heart function better and prevent worsening disease. However, these medications haven't been studied in people with valve disease because most major research studies excluded patients with valve problems.\n\nEven though there is not strong evidence, many doctors prescribe these medications after valve surgery, assuming they might be helpful. But is that really the case? That's the question this study hopes to answer.\n\nWhat Is This Study About?\n\nThis study will test whether losartan, a medication often used for high blood pressure, can help hearts recover better after aortic valve replacement surgery. The researchers will compare two groups of patients:\n\n* One group will take losartan (50 mg per day) after surgery.\n* The other group will take a placebo (a pill with no active medication).\n\nBy comparing these two groups, the study will determine whether losartan helps the heart shrink back to a normal size faster and function better after surgery.\n\nHow Will the Study Work? Who? 60 patients with severe AR who are having aortic valve replacement surgery.\n\nHow? Patients will be randomly placed into one of the two groups (losartan or placebo).\n\nFor how long? Patients will be followed for one year after surgery. What Will Be Measured?\n\nDoctors will check patients four times: before surgery, and 1 month, 3 months, and 12 months after surgery. At each visit, the investigators will measure:\n\n* NT-proBNP levels: A blood test that tells us how much strain the heart is under. Lower levels mean the heart is recovering well.\n* Echocardiogram: An ultrasound of the heart to check its size and function.\n* 6-minute walk test: To see if patients feel stronger and can exercise better.\n* Quality of life survey: To understand how patients feel physically and emotionally.\n* Kidney function and electrolyte levels: To check for medication side effects.\n\nWhy Is This Study Exciting? This is the first study to test whether a medication can help the heart heal better after valve surgery. If losartan proves beneficial, it could change how doctors treat patients after surgery and lead to better recovery, stronger hearts, and healthier lives.\n\nMany people with aortic regurgitation have to wait until their symptoms get worse before patients can have surgery. If this study finds that medication can speed up healing, it could help doctors treat valve disease more effectively and improve long-term outcomes for patients.\n\nWhat Happens Next? If losartan is found to be helpful, this study could lead to larger research trials and, eventually, new treatment guidelines for people who have had aortic valve surgery. If it doesn't help, doctors will know not to prescribe it unnecessarily, preventing unnecessary side effects and costs for patients. Either way, the results will help improve care for people with heart valve disease.\n\nBy participating in this study, patients are helping researchers discover new ways to improve heart health and recovery after surgery.",[162,163,27,164,165],"Heart Valve Diseases","Left Ventricle Remodeling","Heart Failure Congestive","Natriuretic Peptide, Brain",[133,167,168,169,170,171,172,173,174],"valve disease","heart surgery","heart failure","losartan","Brain natriuretic peptide - BNP","biomarkers","renin-angiotensin-aldosterone system","neurohumoral axis","2025-07-29",{"date":177,"type":32},"2025-08-01",{"date":179,"type":32},"2025-07-01",{"date":181,"type":21},"2029-07-01",{"name":183,"class":38},"Vitor Emer Egypto Rosa",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":39},"100580334","impact-of-anesthesia-positive-pressure-ventilation-and-modality-of-imaging-on-the-echocardiographic-assessment-of-the-severity-of-aortic-regurgitation-100580334","NCT06835946","Impact of Anesthesia, Positive Pressure Ventilation and Modality of Imaging on the Echocardiographic Assessment of the Severity of Aortic Regurgitation","Prospective Single-center Observational Trial Aimed at Investigating the Effect of General Anesthesia, Positive Pressure Ventilation and Change of Imaging Modality From Transthoracic Echo to Transesophageal Echo on the Grading of the Severity of Aortic Regurgitation.","Inclusion Criteria:\n\n* Known aortic regurgitation of any grade\n* Scheduled for a cardiac surgery procedure during which a trans-esophageal echo is planned.\n\nExclusion Criteria:\n\n* Non sinus rhythm\n* Mitral regurgitation more than mild.\n* Pre-operative critical state (according to the definition of the EuroSCORE II)\n* Presence of a prosthetic aortic valve\n* Contra-indication to trans-esophageal echo",{"count":127,"type":21},"The goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (TTE) vs trans-esophageal echo (TEE)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency.\n\nPatients scheduled for cardiac surgery and in whom a TEE is going to be performed intra-operatively will be enrolled. The grading of the aortic insufficiency will be compared between a TTE performed immediately before the induction of general anesthesia end the TEE performed after induction of general anesthesia.",[27,194],"Aortic Insufficiency","2025-04-07",{"date":197,"type":32},"2025-04-10",{"date":199,"type":32},"2025-03-01",{"date":201,"type":21},"2027-04-01",{"name":203,"class":38},"University of Liege",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":39},"100568992","valvular-assessment-of-new-generation-aortic-replacement-devices-100568992","NCT06688448","Valvular Assessment of New Generation Aortic Replacement Devices","Comparative Efficacy and Durability of Next-Generation Biological Aortic Prostheses.","VANGUARD","Inclusion Criteria:\n\n* Age: 18 to 65 years.\n* Eligible for surgical replacement of native valve or re-replacement of a prosthetic valve with a bioprosthetic valve in the aortic position.\n\nExclusion Criteria:\n\n* Indicated for mechanical prosthetic valve replacement.\n* Require surgical intervention in another heart valve or transcatheter valve therapy.","65 Years",{"count":214,"type":21},200,[24],"The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement (AVR). This study aims to provide robust data on valve durability, safety, and hemodynamic performance, particularly in younger patients who may require multiple interventions over their lifetimes.",[27,218,219],"Aortic Valve Calcification","Bicuspid Aortic Valve Disease",[221,222,223,224,225],"aortic valve surgery","Dafodil®","Inspires Resilia®","bioprosthetic valves","aortic valve replacement","2025-01-09",{"date":228,"type":32},"2025-01-13",{"date":230,"type":32},"2024-12-01",{"date":232,"type":21},"2036-12-01",{"name":234,"class":38},"Instituto Dante Pazzanese de Cardiologia",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":155,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":255,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":39},"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.",{"count":243,"type":21},160,[24],"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.",[247,248,249,27,250,251,252,253,254],"Heart Failure","Valvulopathy","Aortic Stenosis","Mitral Regurgitation","Tricuspid Regurgitation","Brain Natriuretic Peptide","Mitraclip","TAVI(Transcatheter Aortic Valve Implantation)",[247,249,53,250,251,253,256,108],"Triclip","2024-10-31",{"date":259,"type":32},"2024-11-04",{"date":261,"type":21},"2025-02-01",{"date":263,"type":21},"2026-02-01",{"name":265,"class":38},"IRCCS Ospedale San Raffaele"]