[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transcatheter-aortic-valve-replacement-tavr\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transcatheter-aortic-valve-replacement-tavr":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,75,107,131,153,178,206,239,274],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100641926","evaluation-of-the-safety-and-effectiveness-of-chords-cerebral-protection-system-during-tavr-duet-trial-100641926",false,"NCT07648693","Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial","A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Effectiveness of the Resonova® CHORDS® Cerebral Protection System in Capturing and Removing Embolic Debris During Transcatheter Aortic Valve Replacement","Inclusion Criteria:\n\n* Male or non-pregnant female, ≥18 years\n* Patients with symptomatic severe aortic stenosis who are scheduled to undergo TAVR with commercialized transcatheter aortic valve system.\n* Compatible left common carotid artery (6.5-10 mm) and brachiocephalic artery (9-15mm) diameters without significant stenosis (\\> 70%)\n* Patients who are able to understand the study objectives, voluntarily participate, sign the informed consent form, and are willing to undergo required examinations and clinical follow-up.\n\nExclusion Criteria:\n\nGeneral\n\n* Contraindications to MRI, or planned implantation of an MRI-incompatible device at the index procedure, or planned implantation of an MRI-incompatible pacemaker or defibrillator within 30 days post-procedure.\n* Acute myocardial infarction ≤ 30 days before the intended treatment\n* Pure aortic regurgitation\n* Pre-existing prosthetic aortic valve\n* Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation\n* Contraindication to antiplatelet and\u002For anticoagulant therapy, nitinol , or contrast media, or refusal to receive blood transfusions\n* Vulnerable populations, including those unable to adequately understand the trial, those potentially subject to undue influence or coercion, those unable to complete the informed consent process, and those with severe disabling dementia or cognitive impairment Anatomic\n* Vasculature (ie, right radial\u002Fbrachial artery, carotid artery) precluding the device access\n* Patients whose brachiocephalic or left carotid artery reveals significant stenosis（\\>70%）, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium","ALL","18 Years",{"count":19,"type":20},240,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a prospective, multi-center, randomized controlled study. The goal of the study is to assess the safety and effectiveness of the Resonova® CHORDS® Cerebral Protection System in capturing and removing embolic debris during Transcatheter Aortic Valve Replacement (TAVR). A total of 240 eligible participants will be enrolled and randomized in a 1:1 ratio to undergo TAVR either with the CHORDS® Cerebral Protection System (Test group) or the Sentinel System (Control group).All the participants will be followed up at 30 days and 90 days post-procedure.",[26,27],"Transcatheter Aortic Valve Replacement (TAVR)","Cerebral Vascular Accident (CVA)\u002FStroke",[29,30,31,32],"Cerebral Protection","TAVR","DW-MRI","Stroke","RECRUITING","2026-06-12",{"date":36,"type":37},"2026-06-15","ACTUAL",{"date":39,"type":37},"2025-10-31",{"date":41,"type":20},"2026-12-31",{"name":43,"class":44},"Resonova (Shanghai) Medtech Limited","INDUSTRY",15,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100635733","phase-4-patient-quality-of-recovery-after-tavr-with-different-sedation-regimens-100635733","NCT07556523","Patient Quality of Recovery After TAVR With Different Sedation Regimens","Inclusion Criteria:\n\n* 18-90 years old, inclusive\n* Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)\n* Speaks English or Spanish\n* Consents to participate\n\nExclusion Criteria:\n\n* Preoperative heart rate \\\u003C 50 bpm or arrhythmias (e.g., AFib with RVR)\n* Conduction abnormalities (e.g., 2nd\u002F3rd degree AV block without pacer)\n* Allergy or contraindication to study drugs\n* Pulmonary artery pressure \\> 70mmHg\n* Morbid obesity BMI \\> 50\n* Pregnancy\n* Unable to consent in English or Spanish","90 Years",{"count":54,"type":20},126,[56],"PHASE4","The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure. The main question this study aims to answer is whether different sedation regimens (propofol, dexmedetomidine, or midazolam with fentanyl) lead to differences in quality of recovery on the first day after the procedure.\n\nResearchers will compare three commonly used sedation medications (propofol, dexmedetomidine, or midazolam with fentanyl) to determine whether they lead to differences in recovery following a TAVR.\n\nParticipants will:\n\n* Be enrolled before their scheduled TAVR procedure\n* Be randomly assigned to receive one of the three sedation medications during their procedure\n* Complete short surveys on postoperative days 1 and 7 about pain levels, how they feel during their recovery, and how satisfied they were with their anesthesia experience",[26,59],"Aortic Valve Stenosis",[61,30,62,63],"Transcatheter aortic valve replacement","Sedation strategy","Anesthesia","2026-04-22",{"date":66,"type":37},"2026-04-29",{"date":68,"type":37},"2026-03-16",{"date":70,"type":20},"2028-06",{"name":72,"class":73},"David Lyubashevsky","OTHER",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":74},"100589345","prospective-long-term-evaluation-of-the-sapien-3-ultra-resilia-valve-100589345","NCT06953206","Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve","SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry","RESOUND-EU","Inclusion criteria:\n\n* Adult patients (≥18 years)\n* Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve\n* Patient is willing to attend the follow-up visits up to 10 years at the center\n\nExclusion criteria:\n\n* Lack of written informed consent\n* Emergency procedure\n* Pregnancy at time of TAVI\n\nCritieria for long-term observation (1y-10y):\n\n* Technical success at exit from procedure room (VARC-3):\n\n  * Freedom from mortality\n  * Successful access, delivery of the device, and retrieval of the delivery system\n  * Correct positioning of a single prosthetic heart valve into the proper anatomical location\n  * Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication\n* Absence of the following severe procedural and in-hospital complications (VARC-3 definitions):\n\n  * All stroke\n  * Bleeding type 3-4\n  * Myocardial infarction\n  * Need for a second valve\n  * Valve embolization\n  * Coronary obstruction\n  * Annular rupture",{"count":84,"type":20},500,"OBSERVATIONAL","Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.",[26,88,89,90],"Aortic-Stenosis","Aortic Insufficiency","Degenerative Valve Disease",[30,92,93,94,95],"SAPIEN 3 Ultra RESILIA Valve","S3UR","TAVI","Aortic Stenosis","NOT_YET_RECRUITING","2026-03-25",{"date":99,"type":37},"2026-03-30",{"date":101,"type":20},"2026-03-01",{"date":103,"type":20},"2037-09-30",{"name":105,"class":106},"Institut für Pharmakologie und Präventive Medizin","NETWORK",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":115,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":129,"locationsCount":74},"100621032","frequency-of-electrical-acupoint-stimulation-on-hypotension-in-tavr-patients-100621032","NCT07365345","Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients","The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction in Patients Undergoing TAVR Surgery","FRESH-T","Inclusion Criteria:\n\n* The age of the patients is 60 years or older;\n* Patients who are scheduled to undergo TAVR surgery under general anesthesia;\n\nExclusion Criteria:\n\n* Body mass index less than 18 kg\u002Fm2 or greater than 30 kg\u002Fm2;\n* Hemodynamic instability (severe arrhythmia, decompensated heart failure);\n* Hypotension after admission requiring intervention with vasoactive drugs;\n* Severe liver or kidney dysfunction;\n* Those who are contraindicated for electrical stimulation, including those with local skin damage, infection, or having implanted electrophysiological devices in the body.","60 Years",{"count":117,"type":20},150,[23],"Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan, Jian Shi, and Baihui. The changes in blood pressure during the anesthesia induction period were compared between the high-frequency group and the low-frequency group.",[26,121,122,123],"Hemodynamic Stability","Anesthesia Induction","Electro-acupuncture","2026-03-22",{"date":97,"type":37},{"date":127,"type":37},"2026-01-30",{"date":41,"type":20},{"name":130,"class":73},"Air Force Military Medical University, China",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100628210","tavr-for-aortic-regurgitation-under-tte-guidance-100628210","NCT07458672","TAVR for Aortic Regurgitation Under TTE Guidance","Radiation- and Contrast-Free Transcatheter Aortic Valve Replacement for Aortic Regurgitation Under Transthoracic Echocardiography Guidance","Inclusion Criteria:\n\n* Age ≥18 years.\n* Severe native aortic regurgitation (AR) confirmed by echocardiography (per guideline-recommended multiparametric assessment).\n* Indication for intervention, defined as symptomatic severe AR (e.g., NYHA class II-IV) or asymptomatic severe AR with evidence of LV decompensation (e.g., reduced LVEF and\u002For LV dilation per guideline thresholds).\n* Deemed appropriate for transfemoral TAVR by a multidisciplinary Heart Team (e.g., elevated\u002Fprohibitive surgical risk or other clinical\u002Fanatomic factors favoring transcatheter therapy).\n\nExclusion Criteria:\n\n* Active infective endocarditis or ongoing systemic infection\u002Fsepsis.\n* Aortic pathology requiring open surgery, such as significant ascending aortic aneurysm\u002Froot disease above surgical thresholds, acute aortic syndrome, or other conditions where surgery is mandated.\n* Annulus\u002Flanding-zone dimensions outside device range",{"count":139,"type":20},30,[23],"Transcatheter aortic valve replacement (TAVR) is an established therapy for severe aortic valve disease, yet conventional workflows rely on fluoroscopy and iodinated contrast, exposing patients and operators to ionizing radiation and posing challenges for individuals with chronic kidney disease, contrast allergy, or other contraindications. In patients with native aortic regurgitation, the absence of annular\u002Fleaflet calcification and frequent annular dilation can further complicate device positioning and anchoring, increasing the procedural dependence on precise imaging guidance. Transthoracic echocardiography (TTE) provides real-time assessment of valve anatomy, coaxial alignment, depth control, and immediate hemodynamic results, and-when used as the primary imaging modality-offers a potential \"radiation- and contrast-free\" alternative for selected patients. However, clinical evidence for fully TTE-guided (echo-only) TAVR remains limited. Here, the investigators describe our procedural workflow and evaluate the feasibility and early outcomes of total TTE-guided TAVR for treating aortic regurgitation.",[143,26],"Aortic Regurgitation","2026-03-04",{"date":146,"type":37},"2026-03-09",{"date":148,"type":20},"2026-03-10",{"date":150,"type":20},"2027-12-31",{"name":152,"class":73},"Chinese Academy of Medical Sciences, Fuwai Hospital",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100627950","phenotyping-left-ventricle-failure-with-hemodynamic-biomarkers-from-4d-flow-magnetic-resonance-imaging-100627950","NCT07455292","Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging","TRANSLATE","Inclusion Criteria:\n\n* Adult patients (age \\> 18 years old);\n* Diagnosis of severe AS defined according to ESC guidelines with indication to TAVR;\n* Severe aortic stenosis both in normal\u002Fhigh flow status and in low flow status;\n* Signed informed written consent.\n\nExclusion Criteria:\n\n* Contraindication to cardiac MRI due to previous implant with ferromagnetic components;\n* Poor MRI quality impairing image post-processing;\n* Claustrophobia;\n* Unwilling to sign the informed consent.",{"count":161,"type":20},190,[23],"This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction. The study is designed to achieve the following three objectives.\n\nThe primary objective is to develop a convolutional neural network (CNN)-based deep learning model for the automatic segmentation of the LV endocardial contour throughout the cardiac cycle using intracavitary MRI data. To support model training, a dataset of LV endocardial wall segmentations will be generated from balanced steady-state free precession (bSSFP) images. A purpose-built retrospective MRI database of bSSFP images will be retrieved to accelerate training set creation.\n\nThe secondary objective is to develop a numerical framework for non-invasive MRI-based pressure-volume (PV) loop reconstruction and calculation of simplified hemodynamic force descriptors (HDFs). A prospective cohort of patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) will be enrolled. Pre-procedural non-contrast 4D Flow MRI will be acquired, and non-invasive MRI-derived PV loops will be quantitatively compared with invasive catheter-based PV loop measurements. In addition, simplified HDFs will be compared with 4D Flow-derived HDFs to assess their agreement and their potential to elucidate specific features of heart failure-related LV dysfunction.\n\nThe tertiary objective is to establish the foundation for a unified, standalone, and clinically deployable framework for comprehensive, automated, and clinician-friendly analysis of LV hemodynamics based on 4D Flow MRI. Internal testing, benchmarking, and structured evaluation by clinical end-users with prior 4D Flow MRI research experience will be conducted to collect feedback and guide further development and clinical translation.",[165,26,59],"Left Ventricle Function",[167],"4D Flow MRI","2026-03-02",{"date":170,"type":37},"2026-03-06",{"date":172,"type":37},"2025-10-13",{"date":174,"type":20},"2026-09-30",{"name":176,"class":73},"IRCCS Policlinico S. Donato",2,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":115,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100578960","phase-4-transcatheter-treatment-of-pure-aortic-regurgitation-with-vitaflow-liberty-system-100578960","NCT06818084","TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System","Transcatheter Treatment of Pure Aortic Regurgitation With VitaFlow Liberty System: a Prospective, Multicenter Study","TRAMPERS","Inclusion Criteria Age ≥ 60 years. Symptomatic moderate-to-severe or greater isolated aortic regurgitation.\n\nAsymptomatic moderate-to-severe or greater isolated aortic regurgitation meeting at least one of the following criteria:\n\nLVEF ≤ 55% (measured by biplane Simpson's method); LVESD \\> 50 mm ; LVESDi \\> 22 mm\u002Fmm²； LVESVi \\> 45mL\u002Fm2 Anatomical suitability for TAVR as assessed by the heart team. Provision of written informed consent by the patient or their legal guardian, with agreement to the treatment plan and willingness and ability to comply with all required follow-up assessments.\n\nExclusion Criteria Incomplete coronary revascularization. Less than 30 days of guideline-directed medical therapy at maximally tolerated doses.\n\nLife expectancy \\\u003C 1 year. LVEF \\\u003C 45%. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m². Known allergy or contraindication to required medications (e.g., aspirin, clopidogrel, warfarin) or contrast media.\n\nAny condition that precludes contrast-enhanced CT. Concurrent moderate-to-severe or severe valvular heart disease other than aortic regurgitation.\n\nPoor patient compliance, unable to complete follow-up as required. Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.",{"count":187,"type":20},120,[56],"This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) . This prospective, multicenter trial aims to evaluate the safety and effectiveness of transfemoral TAVR using the VitaFlow™ self-expanding valve system compared to dedicated transcatheter devices in patients with PNAR.\n\nThe primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.\n\nSecondary endpoints include procedure-related complications, long-term clinical events, patient functional status and quality of life, bioprosthetic valve imaging follow-up, echocardiographic parameters, and treatment costs. All endpoint definitions conform to the Valve Academic Research Consortium-3 (VARC-3) criteria",[191,143,26],"AORTIC VALVE DISEASES",[193,194,195,196],"pure aortic regurgitation","Transcatheter aortic valve replacement (TAVR)","hypoattenuated leaflet thickening","reduced leaflet motion","2026-01-27",{"date":127,"type":37},{"date":200,"type":37},"2025-04-29",{"date":202,"type":20},"2027-11-30",{"name":204,"class":73},"Ruijin Hospital",4,{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":215,"studyType":85,"phases":4,"briefSummary":216,"conditions":217,"keywords":226,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":74},"100617119","cardiological-interventions-and-acute-stroke-treatment-study-100617119","NCT07314476","CardioLogical Interventions and Acute strOke Treatment sTudy","CLOT","Inclusion Criteria:\n\n* acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria;\n* stroke with evidence of CT\u002FMRI DWI\u002FFLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h;\n* interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks);\n* written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).\n\nExclusion Criteria:\n\n* Stroke-like symptoms due primarily to another non-ischemic\u002Fhemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc);\n* Spontaneous and post traumatic hemorrhagic stroke or spontaneous\u002Fpost-traumatic subarachnoid hemorrhage or subdural hematoma;\n* AciuImpossibility to achieve written informed consent",{"count":214,"type":20},400,"180 Days","The study aims to investigate characteristics and prognosis of ischemic stroke cases following cardiological interventions, focusing on the effectiveness and safety of acute ischemic stroke treatments.",[218,219,220,221,26,222,223,224,225],"Acute Ischemic Stroke AIS","Stroke Treatment","PCI Patients","Aortic Valve Replacement","Mitral Valve Repair","Mitral Valve Replacement","Left Atrial Appendage Closure","Transcatheter Pulmonary Valve Replacement (TPVR)",[227,228,229],"acute ischemic stroke","acute ischemic stroke treatments","cardiological intervention","2026-01-04",{"date":232,"type":37},"2026-01-07",{"date":234,"type":20},"2026-01",{"date":236,"type":20},"2028-12",{"name":238,"class":73},"University of L'Aquila",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":249,"conditions":250,"keywords":262,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":45},"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":248,"type":20},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.",[251,252,253,254,255,59,256,257,258,259,260,26,225,261],"Heart Valve Disease","Mitral Valve (MV) Regurgitation","Mitral Valve Disease","Mitral Valve Stenosis","Aortic Valve Disease","Tricuspid Valve Disease","Tricuspid Valve Regurgitation","Aortic Valve Regurgitation","Pulmonary Valve Disease","Transcatheter Valve Replacement","Transcatheter Edge-to-edge Repair",[263,264],"Heart Valve Disease Progression","Heart Valve disease sequelae","2025-11-25",{"date":267,"type":37},"2025-12-05",{"date":269,"type":37},"2025-06-01",{"date":271,"type":20},"2030-05-31",{"name":273,"class":73},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":21,"phases":283,"briefSummary":284,"conditions":285,"keywords":288,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":74},"100601213","assessment-of-coronary-artery-disease-before-transcatheter-aortic-valve-replacement-a-randomized-multicenter-non-inferiority-trial-100601213","NCT07107568","Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial","TAVR-CT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Severe aortic valve stenosis and indication for intervention according to current European Society of Cardiology (ESC) guidelines\n* TAVR candidate\n* Written informed consent\n\nExclusion Criteria:\n\n* Cardiogenic shock at presentation (e.g., emergency indication for TAVR)\n* Severe renal impairment with an estimated glomerular filtration rate of \\\u003C30 mL\u002Fmin\u002F1.73 m²\n* Life expectancy \\\u003C1 year due to other severe non-cardiac disease (e.g., malignancy)\n* Pregnancy",{"count":282,"type":20},700,[23],"The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.",[286,287,26],"Aortic Valve Stenosis and Insufficiency","Coronary Artery Disease(CAD)",[279,289,290,291,30,292,293],"PCD-CT","Severe Aortic Stenosis","Transcatheter Aortic Valve Replacement","Photon-Counting Detector CT","Randomized Controlled Trial","2025-08-18",{"date":296,"type":37},"2025-08-22",{"date":298,"type":37},"2025-08-14",{"date":300,"type":20},"2029-12-31",{"name":302,"class":73},"Medical University Innsbruck"]