[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tavitranscatheter-aortic-valve-implantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tavitranscatheter-aortic-valve-implantation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,40,71,96,126,156,181,208,240,263,286,314,343,364,380,395,423,455],{"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":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100623650","radial-versus-femoral-secondary-access-in-patients-undergoing-tavi-100623650",false,"NCT07399392","Radial Versus Femoral Secondary Access in Patients Undergoing TAVI","RADIAL-TAVI","Inclusion Criteria:\n\n* Patients scheduled for transfemoral TAVI\n* Heart team agrees on eligibility of TAVI\n* Written informed consent\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Non accessible radial arteries as judged by the TAVI team\n* Non accessible femoral arteries as judged by the TAVI team\n* Foreseeable problems to achieve primary transfemoral access (hostile access)\n* Hemodynamic instability or cardiogenic shock\n* Currently participating in an investigational drug or another device study\n* Lack of capability to give informed consent\n* Patient refuses TAVI","ALL","18 Years",{"count":19,"type":20},600,"ESTIMATED","INTERVENTIONAL",[23],"NA","Severe symptomatic aortic stenosis (AS) with a high gradient is associated with a poor prognosis if not treated with valve replacement. Transcatheter aortic valve implantation has been shown in large randomized trials to be a safe and effective treatment option for patients at low, intermediate, or high risk. Transfemoral access for heart valve replacement is by far the most commonly used approach, as it is relatively easy to control and has a low complication rate compared to other access routes.\n\nThe TAVI procedure requires two arterial access points: one with a large lumen for the TAVI prosthesis via the femoral artery, and a smaller second one for a pigtail catheter that guides the TAVI prosthesis into the optimal position. This secondary access is most often via a second artery.\n\nVascular complications are the most commonly observed complications in transfemoral TAVI and are associated with poorer procedural outcomes.\n\nRecent data suggest that secondary vascular access via the radial artery may contribute to a reduction in vascular complications after TAVI. In patients undergoing coronary angiography and\u002For percutaneous coronary intervention, radial access has become the preferred strategy due to its proven reduction in vascular complications compared to femoral access. The use of radial access is associated with a lower incidence of vascular complications compared to femoral access.\n\nRecent non-randomized data suggest that radial access may be a safer alternative to traditional femoral access as a secondary arterial access in transfemoral TAVI. However, non-randomized retrospective comparisons are subject to selection bias and underreporting of complications. Therefore, a prospective randomized trial is needed to evaluate the value of radial access for secondary arterial access in patients undergoing transfemoral TAVI.",[26],"TAVI(Transcatheter Aortic Valve Implantation)","RECRUITING","2026-06-01",{"date":30,"type":31},"2026-06-02","ACTUAL",{"date":33,"type":31},"2025-07-01",{"date":35,"type":20},"2028-12-31",{"name":37,"class":38},"University Heart Center Freiburg - Bad Krozingen","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100639850","phase-3-finerenone-in-patients-undergoing-transcatheter-aortic-valve-implantation-with-heart-failure-100639850","NCT07575672","Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure","Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure: A Prospective, Multicenter, Randomized, Placebo-Controlled Trial","FINE-VALUE","Inclusion Criteria:\n\n1. Age ≥ 65 years.\n2. Patients with severe aortic stenosis (aortic valve area \\\u003C 1.0 cm2 or indexed area \\\u003C 0.6 cm2\u002Fm2, or mean transvalvular aortic gradient ≥ 40 mmHg or velocity of blood flow through the valve ≥ 4.0 m\u002Fs) undergoing transfemoral TAVI.\n3. New York Heart Association class ≥ II.\n4. Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.\n5. Informed consent has been signed.\n\nExclusion Criteria:\n\n1. Untreated serum\u002Fplasma potassium \\> 5.0 mmol\u002FL during the screening period or randomization visit.\n2. Estimated glomerular filtration rate \\\u003C 25 ml\u002Fmin\u002F1.73 m².\n3. Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.\n4. Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.\n5. Pregnant or breastfeeding patients.\n6. Life expectancy \\\u003C 1 year.\n7. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.","65 Years",{"count":50,"type":20},2832,[52],"PHASE3","This study is a multicenter, double-blind, randomized, placebo-controlled trial. The purpose is to evaluate whether treatment with finerenone in patients with symptomatic severe aortic stenosis undergoing TAVI, and heart failure with LVEF ≥40% is associated with a reduction in the composite endpoint of all-cause mortality or worsening of heart failure. Participants are patients with symptomatic aortic stenosis undergoing TAVI and heart failure with LVEF≥40%. Eligible patients will be randomly assigned in a 1:1 ratio to either the finerenone group or the placebo group. Patients meeting all inclusion criteria and not any exclusion criteria will be invited to participate before discharge. All enrolled patients will consecutively receive treatment, during which serum potassium and estimated glomerular filtration rate will be closely monitored. Follow-up will be conducted at 30 days, 12 months at clinic, and 3 months, 6 months, 9 months and every 6 months after 12 months of enrollment online or via telephone (at clinic if necessary). The final visit will be conducted for all enrolled patients at the end of the study.",[55,26,56],"HFpEF - Heart Failure With Preserved Ejection Fraction","Finerenone",[58,59,56],"HFpEF","TAVI","NOT_YET_RECRUITING","2026-05-04",{"date":63,"type":31},"2026-05-08",{"date":65,"type":20},"2026-07-01",{"date":67,"type":20},"2029-12-31",{"name":69,"class":38},"Second Affiliated Hospital, School of Medicine, Zhejiang University",61,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":39},"100633903","respiratory-and-haemodynamic-effects-of-conscious-sedation-with-dexmedetomidine-for-a-tavi-procedure-100633903","NCT07532733","Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure","Respiratory and Haemodynamic Effects Comparison of Conscious Sedation With Dexmedetomidine Versus Sedation With Remifentanil-propofol for a TAVI Procedure: a Prospective, Randomised, Single-blind Study","Inclusion Criteria:\n\n* -aged 60 or over,\n* undergoing transfemoral TAVI,\n* treated under sedation without general anaesthesia,\n* having given their written informed consent,\n* with sufficient command of French to undertake cognitive tests.\n\nExclusion Criteria:\n\n* whose first language is not English,\n* who have a contraindication to dexmedetomidine,\n* who require conversion to general anaesthesia during the procedure,\n* or who present with major haemodynamic instability (shock, uncontrolled arrhythmia).","60 Years",{"count":80,"type":20},80,[23],"Transcatheter aortic valve implantation (TAVI) is now the standard procedure for elderly patients with severe aortic stenosis. This patient group is characterised by increased frailty, multiple comorbidities and limited physiological reserve, exposing them to an increased risk of intraoperative complications.\n\nThe majority of TAVI procedures are now performed under conscious sedation, in order to limit the risks associated with general anaesthesia and to promote a faster recovery. However, this strategy carries a risk of intraoperative respiratory events, notably bradypnoea, oxygen desaturation and airway obstruction, particularly in elderly patients with comorbidities.\n\nThe anaesthetic strategy, and in particular the type of sedation used, is likely to influence intraoperative respiratory and haemodynamic tolerance. Traditionally used agents, such as propofol combined with opioids, can induce dose-dependent respiratory depression. Conversely, dexmedetomidine, an α2-adrenergic receptor agonist, has a distinct pharmacological profile, characterised by sedation with a theoretically limited respiratory impact.\n\nHowever, comparative data regarding the impact of different sedation strategies on intraoperative respiratory tolerance during TAVI remain limited, justifying the conduct of this study.\n\nDexmedetomidine is a selective α2-adrenergic receptor agonist, used in anaesthesia and intensive care for its sedative and anxiolytic properties. It induces what is known as 'cooperative' sedation, characterised by the maintenance of relative alertness, the possibility of interacting with the patient and, above all, a limited impact on spontaneous breathing.\n\nPhysiologically, dexmedetomidine differs from conventional sedatives, such as propofol and opioids, in causing less respiratory depression, making it a particularly attractive option for conscious sedation. This property is essential in elderly and comorbid patients, particularly during procedures such as TAVI, where maintaining spontaneous ventilation is a major concern.\n\nSeveral clinical studies, particularly in procedural sedation and interventional cardiology, suggest that the use of dexmedetomidine is associated with better respiratory tolerance, with a reduction in episodes of desaturation, bradypnoea and the need for airway interventions, compared with strategies based on propofol and opioids.\n\nHowever, data specific to the context of TAVI under conscious sedation remain limited, particularly regarding the prospective and standardised assessment of intraoperative respiratory events.\n\nThis study therefore aims to address this knowledge gap by assessing the effect of dexmedetomidine, compared with standard sedation using propofol-remifentanil, on intraoperative respiratory tolerance in patients undergoing TAVI under conscious sedation.",[26],[59,85,86],"sedation","dexmedetomidine","2026-04-27",{"date":89,"type":31},"2026-04-30",{"date":91,"type":31},"2026-04-22",{"date":93,"type":20},"2027-06-30",{"name":95,"class":38},"Erasme University Hospital",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":39},"100617375","phase-4-echo-guided-vs-fluoroscopy-guided-transcatheter-aortic-valve-replacement-in-patients-with-aortic-stenosisecho-tavr-100617375","NCT07317804","Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis（ECHO-TAVR）","Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis","ECHO-TAVR","Inclusion Criteria:\n\n* 1\\. Patients aged 70 years or older with obvious clinical symptoms or a left ventricular ejection fraction less than 50% due to severe aortic valve stenosis (aortic valve orifice area \\\u003C 1.0 cm² or peak velocity ≥ 4.0 m\u002Fs or mean transvalvular pressure ≥ 40 mmHg); or patients with obvious clinical symptoms of low blood flow and low pressure difference aortic valve stenosis (effective aortic valve orifice area \\\u003C 1.0 cm², mean transvalvular pressure difference \\\u003C 40 mmHg, left ventricular ejection fraction \\\u003C 50%, stroke volume index \\\u003C 35 ml\u002Fm², and diagnosed as true severe aortic valve stenosis by dobutamine stress test);\n* 2\\. Patients aged 65 years ≤ age \\\u003C 70 years with severe aortic stenosis who have surgical contraindications or high risks, or have other risk factors such as post-chest radiotherapy, liver failure, diffuse severe aortic calcification, extreme weakness, etc., or patients refuse to undergo routine open-chest surgery;\n* 3\\. The patient's anatomical structure is suitable for TAVR and can tolerate transesophageal ultrasound;\n* 4\\. The patient has signed the informed consent form and is willing to participate in this study.\n\nExclusion Criteria:\n\n* 1\\. Imaging (ultrasound and\u002For CT and\u002For MRI) confirmed a lesion, thrombus or calculus in the left ventricle;\n* 2\\. Severe obstruction of the left ventricular outflow tract;\n* 3\\. Severe right ventricular dysfunction;\n* 4\\. Acute myocardial infarction within 30 days before the procedure;\n* 5\\. Active endocarditis history within 180 days before the procedure;\n* 6\\. Inappropriate aortic root anatomy (such as combined aortic dissection, excessive aortic annulus, risk of coronary artery occlusion, etc.);\n* 7\\. Severe calcification and distortion of the surgical approach;\n* 8\\. Left ventricular ejection fraction less than 20%;\n* 9\\. Other cardiac diseases that require concurrent treatment (such as severe mitral regurgitation, atrial fibrillation, etc.);\n* 10\\. History of stroke or transient ischemic attack within 90 days before the procedure;\n* 11\\. Liver cirrhosis or active liver disease;\n* 12\\. Renal insufficiency (creatinine clearance rate \\\u003C 30 mL\u002Fmin) and\u002For undergoing renal replacement therapy;\n* 13\\. Unable to tolerate anticoagulation therapy during or after the procedure;\n* 14\\. Participating in other drug or device research;\n* 15\\. Any emergency or surgical operation within 30 days before the procedure;\n* 16\\. Other severe comorbidities, even if the valve stenosis is corrected, the expected life expectancy is less than 1 year;\n* 17\\. Other conditions deemed unsuitable for TAVR surgery by the cardiac team.",{"count":105,"type":20},212,[107],"PHASE4","Aortic stenosis (AS) is a common valvular heart disease whose prevalence increases markedly with age-approximately 2-4% in individuals aged 65 years and older, and up to 3.4% for severe AS in those over 75. Degenerative calcific AS predominates in high-income countries, whereas rheumatic disease remains a major cause in low-income regions. With global population aging, the disease burden of AS continues to rise.\n\nTranscatheter aortic valve replacement (TAVR\u002FTAVI), owing to its minimally invasive nature, has become an important treatment option for severe AS and selected aortic regurgitation patients, expanding from high-surgical-risk populations to those at intermediate and low risk. In recent years, the number of TAVR procedures in many regions has surpassed or approached that of surgical aortic valve replacement, and major clinical guidelines have elevated TAVR to a recommended standard therapy.\n\nConventional TAVR relies on combined fluoroscopic and echocardiographic guidance. However, perioperative complications remain frequent in elderly and high-risk patients, particularly acute kidney injury (AKI), which significantly increases short- and long-term mortality. Contrast exposure during the procedure is a major contributor to AKI; thus, clinical practice increasingly favors strategies that minimize contrast use, such as low-dose and low-kV imaging. Elevated contrast concentration in the renal tubules increases viscosity, prolongs renal exposure, and can lead to tubular injury and renal dysfunction. Continuous radiation exposure during vascular access, device positioning, valve deployment, and post-release assessment also poses safety concerns for both patients and medical staff.\n\nEchocardiography-only guidance for TAVR has therefore emerged as an attractive alternative, with the potential to replace fluoroscopy and contrast for anatomical visualization and device positioning, thereby reducing radiation exposure and contrast-related kidney injury. However, no prospective randomized study has directly compared echocardiography-only guidance with conventional fluoroscopy-plus-echocardiography guidance, and current evidence remains preliminary.\n\nTo address this gap, a randomized controlled trial was designed to evaluate whether echocardiography-only guidance is non-inferior to combined fluoroscopic and echocardiographic guidance in terms of device success, while also assessing the safety, efficacy, and clinical feasibility of both approaches.",[110,59,26],"Aortic Stenosis",[112,113,26,59,110,114,115],"Ultrasound-guided","Percutaneous Intervention","PAN Procedure","non fluoroscopic","2026-04-16",{"date":118,"type":31},"2026-04-21",{"date":120,"type":20},"2026-04-26",{"date":122,"type":20},"2028-07-31",{"name":124,"class":125},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":143,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100633062","remote-ecg-monitoring-post-tavi-100633062","NCT07521800","Remote ECG Monitoring Post TAVI","Remote ECG Monitoring as a Diagnostic Tool for Therapeutic Strategies After Transcatheter Aortic Valve Replacement: Rationale and Design of the DRAGON-TAVI Trial.","DRAGON-TAVI","Inclusion Criteria:\n\n* Patient age over 18 years old\n* Severe aortic stenosis\n* Moderate or high cardiovascular risk based on current ESC Guidelines \"Heart Team\" qualification for TAVI\n* Written informed consent of the patient for participation in the study\n\nExclusion Criteria:\n\n* History of atrial fibrillation or atrial flutter\n* Previously known conduction disturbances\\*\\*\n* Presence of: pacemaker, CRT-P, ICD, CRT-D before or after TAVI\n* Ischaemic stroke, TIA, MI or heart surgery within 1 month before TAVI qualification\n* Haemorrhagic stroke within 1 year before TAVI qualification\n* Chronic immunosuppressive therapy\n* Comorbidities (e.g. drug addiction, alcohol abuse, emotional\u002Fmental disorders) which do not allow safe participation in the study",{"count":135,"type":20},250,[23],"The DRAGON TAVI study is a multicenter, prospective, open, randomised trial, which will enrol 250 patients, randomized 1:1 to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and standard care (ie. control group, which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days). The duration of the study is 12 months ± 1 month.",[26,139,140,141,142],"Remote Monitoring","Arrythmia","Atrial Fibrillation (AF)","Atrioventricular Block",[59,144,145],"ECG","Monitoring","2026-04-07",{"date":148,"type":31},"2026-04-13",{"date":150,"type":31},"2023-12-01",{"date":152,"type":20},"2028-02-01",{"name":154,"class":38},"Medical University of Silesia",4,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":164,"maxAge":4,"enrollmentInfo":165,"targetDuration":167,"studyType":168,"phases":4,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":39},"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":166,"type":20},300,"3 Months","OBSERVATIONAL","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.",[26,171],"Aortic Valve Disease","2026-03-10",{"date":174,"type":31},"2026-03-11",{"date":176,"type":31},"2026-01-12",{"date":178,"type":20},"2028-03",{"name":180,"class":38},"dr Pim A.L. Tonino",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100626025","dilation-optimisation-for-uniform-bioprosthetic-leaflet-expansion-100626025","NCT07430267","Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion","Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial","ACE-DOUBLE","Inclusion Criteria:\n\n* Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra\u002FRESILIA balloon-expandable transcatheter heart valve.\n* Tricuspid or bicuspid aortic valve stenosis\n\nExclusion Criteria:\n\n* Valve-in-valve TAVI for failure of an existing prosthetic surgical or transcatheter valve failure\n* TAVI performed for native valve aortic regurgitation\n* High risk 'hostile' annular anatomy as adjudicated by multidisciplinary Heart Team based on pre-procedure CT anatomy.",{"count":135,"type":20},[23],"The goal of this clinical trial is to discover if routine 'double tap' balloon post-dilation improves valve expansion and clinical outcomes in adults undergoing Transcatheter Aortic Valve Implantation (TAVI) with the SAPIEN balloon-expandable TAVI prosthesis.\n\nThe primary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve expansion. The secondary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve haemodynamic performance.\n\nParticipants will be randomised to balloon-expandable TAVI either with or without routine 'double tap' balloon post-dilation.",[110,26],[59,194,195,196,197],"TAVR","Double Tap","balloon post-dilation","Balloon-expandable TAVI","2026-02-18",{"date":200,"type":31},"2026-02-24",{"date":202,"type":20},"2026-04-01",{"date":204,"type":20},"2029-04-01",{"name":206,"class":38},"The Alfred",3,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":224,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":39},"100621443","phase-4-iron-infusion-in-patients-undergoing-transcatheter-aortic-valve-implantation-100621443","NCT07370688","Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation","Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation: Study Protocol of the Randomized Controlled IRON-TAVI Trial","IRON TAVI","Inclusion Criteria:\n\n* Patient age ≥ 65 years\n* Patients with severe AS and ID undergoing successful TAVI\n* ID defined as Ferritin \\\u003C 100 ug\u002FL and\u002For Transferrin saturation \\\u003C 20%\n* Ability to perform assessment of QoL (questionnaire assessment) and EC (6-MWT)\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Contra-indication for TAVI\n* Ferritin \\> 400 ug\u002FL\n* Hemoglobin \\\u003C5.6 mmol\u002FL or \\\u003C9 g\u002FdL\n* Hemoglobin \\>8.7 mmol\u002FL or \\>14 g\u002FdL in men and \\>8.1 mmol\u002FL or \\>13 g\u002FdL in women\n* Anaemia due to known reasons other than ID and\u002For anticipated non-response to iron-supplementation (e.g. hemogobinopathy, bone marow disease, active cancer, unresolved active bleeding)\n* Chronic liver disease (including active hepatitis) and\u002For screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.\n* Renal dialysis (previous, current, or planned within the next 6 months) or MDRD\u002FCKD-EPI estimated glomerular filtration rate \\\u003C15 mL\u002Fmin.\n* History of iron overload\n* History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 3 months and\u002For such therapy planned within next 6 months\n* Clinically apparent infection requiring antibiotic treatment\n* Known hypersensitivity to iFCM or to any of its excipients\n* Pregnancy\n* Study subject participation in another TAVI related clinical study in which the primary endpoint includes mortality, hospitalization for heart failure and\u002For quality of life assessment.",{"count":217,"type":20},402,[107],"The aim of the open-label, randomized controlled superiority IRON TAVI trial is to investigate whether intravenous iron therapy (ferric carboxymaltose) improves Health-Related Quality of Life (HRQOL) in patients with severe aortic stenosis (AS) and iron deficiency (ID), undergoing transcatheter aortic valve implantation (TAVI).\n\nThe main questions it aims to answer are:\n\n1. Does intravenous iron therapy improve HRQOL after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?\n2. Can intravenous iron therapy enhance exercise capacity, as measured by the 6-minute walk test, after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?\n\nThe intervention group (receiving iron therapy after TAVI) will be compared to the control group (receiving no iron therapy after TAVI (standard of care)).\n\nParticipants will:\n\n* Provide written informed consent\n* Be randomly assigned to one of two groups:\n\n  1. Intervention group: receiving intravenous iron therapy after TAVI (1-3 administrations in the course of 12 weeks)\n  2. Control group: receiving standard of care (= no iron therapy)\n* Complete assessments of HRQOL and the 6-minute walk test at baseline and week 24 after TAVI.\n* During follow-up visits, other clinical parameters will be collected (i.e. laboratory status, mortality status, adverse clinical events)",[221,222,26,223],"Aortic Valve Stenosis","Iron Deficiency","Cardiovascular Diseases",[225,226,227,221,228,229,230,222,223],"Health-related Quality of Life","Six-Minute Walk Test","Randomized Controlled Trial","Intravenous Iron Therapy","Kansas City Cardiomyopathy Questionnaire","Functional Recovery","2026-01-18",{"date":233,"type":31},"2026-01-27",{"date":235,"type":31},"2024-08-12",{"date":237,"type":20},"2028-07",{"name":239,"class":38},"Erasmus Medical Center",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":168,"phases":4,"briefSummary":249,"conditions":250,"keywords":251,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"100578987","portuguese-registry-with-meril-myval-thv-series---myportuval-registry-100578987","NCT06818435","Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry","MyPORTuVal","Inclusion Criteria:\n\n1. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS), intended to perform TAVI procedure using Myval THV series as assessed by Heart Team.\n2. Patient has provided written informed consent as approved by the Ethics Committee (EC)\n3. Patient is willing to undergo all registry procedures and follow-up requirements\n\nExclusion Criteria:\n\n1. Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.\n2. Ongoing infective endocarditis or any similar infection.\n3. Pregnant or lactating females.\n4. Liver failure (Child-Pugh Class B or C)\n5. Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved.\n6. Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.",{"count":248,"type":20},150,"A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.",[221,26],[245,59,252],"Portuguese TAVI Registry","2026-01-15",{"date":255,"type":31},"2026-01-16",{"date":257,"type":31},"2025-05-13",{"date":259,"type":20},"2028-11",{"name":261,"class":38},"Portuguese Association of Interventional Cardiology",6,{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":168,"phases":4,"briefSummary":272,"conditions":273,"keywords":276,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":39},"100596945","impact-of-transcatheter-aortic-valve-implantation-tavi-on-the-gut-microbiota-in-patients-with-aortic-valve-stenosis-100596945","NCT07052071","Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis","GUT-TAVI","Inclusion Criteria:\n\n* Aortic stenosis suitable for TAVI\n\nExclusion Criteria:\n\nPatients will be excluded if they present any condition or intervention that may independently affect gut microbiota composition. These include:\n\n* Use of antibiotics, systemic corticosteroids, antivirals, probiotics, bile acid sequestrants, or new medications within one month prior to enrollment.\n* History of inflammatory bowel disease.\n* End-stage renal disease requiring dialysis.\n* End-stage chronic liver disease.\n* Acute infection. Patients with aortic stenosis due to rheumatic fever or infectious endocarditis will be excluded.\n* Active cancer under treatment.\n* Psychiatric illness impairing ability to consent.\n* Substance or alcohol abuse.",{"count":271,"type":20},40,"This study investigates the impact of transcatheter aortic valve implantation (TAVI) on the composition and function of the gut microbiota in patients with severe aortic valve stenosis. The improvement in haemodynamics following TAVI may positively influence gut microbial balance by increasing splanchnic perfusion and reducing intestinal congestion. A total of 40 patients undergoing TAVI at the \"Hippokration\" General Hospital of Athens will be enrolled, with the aim of analysing stool and blood samples before and after the procedure. The primary endpoint is the change in gut microbiota composition two months post-TAVI, assessed via 16S rRNA sequencing. Secondary endpoints include changes in serum TMAO levels and their association with the severity of aortic stenosis and post-procedural valve haemodynamics. Data will be collected at two timepoints (1 month up to 1 day pre-TAVI and 3 to 4 months post-TAVI), along with dietary questionnaires to account for potential confounding factors. This observational study aims to highlight the potential relationship between cardiac function and the gut microbiome, offering new perspectives for targeted therapeutic strategies in cardiovascular disease.",[110,274,275,59,26],"Gut Microbiome","Gut Microbiota",[59],"2025-11-14",{"date":279,"type":31},"2025-11-18",{"date":281,"type":31},"2025-09-01",{"date":283,"type":20},"2027-11-01",{"name":285,"class":38},"Hippocration General Hospital",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":293,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":168,"phases":4,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":39},"100608423","biomarkers-of-inflammation-and-fibrosis-in-conduction-disorders-after-tavi-100608423","NCT07201363","Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI","The Role of Inflammation and Fibrosis in the Development of Conduction Disorders After Transcatheter Aortic Valve Implantation","Inclusion Criteria:\n\n* Written consent to participate in the trial\n* Diagnosis of severe AS according to current European Society of Cardiology (ESC) guidelines for valvular heart disease\n\nExclusion Criteria:\n\n* Acute infectious disease\n* Chronic inflammatory or autoimmune disease\n* Corticosteroid or other immunosuppressive therapy\n* Active malignant disease\n* Liver disease accompanied by dysfunction\n* Permanent pacemaker implanted previously\n* An acute myocardial infarction within three months before the procedure\n* A surgical procedure within three months before the procedure\n* Previous surgical or transcatheter aortic valve replacement\u002Fimplantation\n* End-stage chronic kidney disease (eGFR \\\u003C15 ml\u002Fmin)",true,{"count":295,"type":20},102,"Prediction of conduction disorders (CDs) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) is an important and complex process with a significant impact on patient outcomes. The goal of this observational prospective trial is to investigate the role of pre-procedural values of systemic biomarkers of inflammation and fibrosis in the prediction of new-onset CDs and permanent pacemaker implantation (PPI) in patients undergoing the TAVI procedure.",[26,298,110,299],"Conduction Disorder","Permanent Pacemaker Implantation",[110,301,298,302,303,304],"Biomarkers","Fibrosis","Inflammation","Transcatheter Aortic Valve Implantation","2025-09-30",{"date":307,"type":31},"2025-10-06",{"date":309,"type":31},"2024-12-12",{"date":311,"type":20},"2026-08",{"name":313,"class":38},"Clinical Hospital Center Rijeka",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":322,"targetDuration":167,"studyType":168,"phases":4,"briefSummary":324,"conditions":325,"keywords":328,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":39},"100607780","quality-of-life-improvement-after-tavi-qualitavi-uk-trial-100607780","NCT07193004","Quality of Life Improvement After TAVI (QualiTAVI-UK Trial)","Quality of Life Improvement After Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK Trial)","QualiTAVI-UK","Inclusion Criteria:\n\n* Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.\n\nExclusion Criteria:\n\n* Patients who declined enrollment in this research.",{"count":323,"type":20},100,"Transcatheter aortic valve implantation (TAVI) has become an important therapeutic intervention for patients with symptomatic severe aortic stenosis (AS) who are at high surgical risk. While the clinical outcomes of TAVI are well established, there is limited data on the long-term quality of life (QoL) following the procedure. This prospective study will assess QoL in patients undergoing TAVI at Derriford Hospital, University Hospitals Plymouth, UK. Investigators will employ the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and Mini-Montreal Cognitive Assessment (Mini-MoCA) to evaluate both physical and mental health outcomes, supplemented by an analysis of life expectancy estimated by a multidisciplinary team (MDT). Data will be collected at referral, pre-procedural, 30 days, and 3 months post-TAVI. This will be the first prospective trial focused on QoL improvement after TAVI, as all previous studies have been retrospective in nature. The study aims to provide comprehensive insights into the QoL improvements after TAVI, which will guide future clinical decision-making in this population.",[26,59,326,327],"Quality of Life","Mental Health",[329,330,229,331,332,333,334],"Transcatheter aortic valve implantation (TAVI)","quality of life","Mini-Montreal Cognitive Assessment (Mini-MoCA)","life expectancy","Mental health","Clinical Frailty Scale (CFS)","2025-09-24",{"date":305,"type":31},{"date":338,"type":20},"2025-11-01",{"date":340,"type":20},"2027-02-01",{"name":342,"class":38},"University Hospital Plymouth NHS Trust",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":21,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":4},"100604673","rotao-1---feasibility-and-safety-of-the-tavipilot-tele-operated-robot-during-transcatheter-aortic-valve-replacement-tavrtavi-100604673","NCT07152574","ROTAO 1 - Feasibility and Safety of the TAVIPILOT Tele-operated Robot During Transcatheter Aortic Valve Replacement (TAVR\u002FTAVI)","Inclusion Criteria:\n\n1. Patients aged ≥65\n2. Indicated for transfemoral TAVR for severe aortic stenosis",{"count":350,"type":20},10,[23],"The TAVIPILOT tele-operated robot by Caranx Medical is an advanced intraoperative robotic assistance system designed to enhance the precision of transcatheter aortic valve positioning during TAVR. The system integrates with standard procedural workflows and enables remote manipulation of delivery system components, allowing for controlled, stable, and reproducible movements. TAVIPILOT facilitates accurate valve alignment and deployment, reducing operator variability. The robot is compatible with approved balloon-expandable transcatheter heart valves (Sapien 3 and Ultra, Edwards Lifesciences, USA) and standard catheterization lab infrastructure.",[26],"2025-08-26",{"date":356,"type":31},"2025-09-03",{"date":358,"type":20},"2025-09-15",{"date":360,"type":20},"2026-02-15",{"name":362,"class":363},"Caranx Medical","INDUSTRY",{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":369,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":21,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":378,"leadSponsor":379,"locationsCount":4},"100602315","feasibility-and-safety-of-the-augmented-reality-guidance-software-tavipilot-software-during-transcatheter-aortic-valve-replacement-tavrtavi-in-australia-100602315","NCT07121907","Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR\u002FTAVI) in Australia","SAITO 1B",{"count":350,"type":20},[23],"The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI. It works alongside conventional fluoroscopy, using real-time image analysis to provide precise anatomical landmarks. TAVIPILOT Software detects key anatomical structures, tracks valve positioning, and uses AI-based confidence indicators to assist in alignment. The software is compatible with approved C-arm imaging systems and specific catheter models.\n\nThe objective is to assess the feasibility and safety of the TAVIPILOT Software augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly and to reduce implantation depth variations.",[26],"2025-08-12",{"date":376,"type":31},"2025-08-14",{"date":358,"type":20},{"date":360,"type":20},{"name":362,"class":363},{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":369,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":21,"phases":386,"briefSummary":372,"conditions":387,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":392,"leadSponsor":394,"locationsCount":4},"100600657","feasibility-and-safety-of-the-augmented-reality-guidance-software-tavipilot-software-during-transcatheter-aortic-valve-replacement-tavrtavi-100600657","NCT07100340","Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR\u002FTAVI)",{"count":350,"type":20},[23],[26],"2025-07-28",{"date":390,"type":31},"2025-08-03",{"date":358,"type":20},{"date":393,"type":20},"2026-03-15",{"name":362,"class":363},{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":21,"phases":404,"briefSummary":405,"conditions":406,"keywords":410,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":39},"100594234","cerebral-regional-oxygen-saturation-during-tavi---the-cros-tavi-prospective-registry-100594234","NCT07016789","Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry","Cerebral Regional Oxygen Saturation During TAVI: A Prospective Comparison of Balloon-Expandable and Self-Expanding Valves","CROS-TAVI","Inclusion Criteria:\n\nSigned informed consent prior to any study-specific procedures\n\nDiagnosis of severe degenerative aortic valve stenosis with echocardiographic criteria:\n\nMean gradient \\> 40 mm Hg, or\n\nJet velocity \\> 4.0 m\u002Fs, or\n\nAortic valve area (AVA) \\\u003C 0.8 cm² (or AVA index \\\u003C 0.5 cm²\u002Fm²)\n\nSymptomatic aortic stenosis defined as NYHA functional class ≥ II\n\nExclusion Criteria:\n\nSymptomatic carotid artery disease or indication for carotid revascularization\n\nCardiogenic shock or inotropic support required prior to the procedure\n\nActive neurodegenerative disease\n\nContraindications as determined by anesthesiology screening\n\nAge \\\u003C 18 years\n\nContraindications to NIRS monitoring\n\nST-elevation myocardial infarction or cardiogenic shock within 48h before enrollment\n\nEmergency TAVI due to decompensated AV stenosis\n\nMalignancy or comorbidities with life expectancy \\\u003C 12 months\n\nInability to comply with the study protocol\n\nStroke or transient ischemic attack within 6 months\n\nRenal insufficiency (creatinine \\> 3.0 mg\u002FdL) or dialysis dependency\n\nSevere left ventricular dysfunction (LVEF \\\u003C 30%)\n\nSignificant mixed valvular disease (e.g., severe mitral or tricuspid regurgitation)\n\nIntracardiac mass, thrombus, or vegetation\n\nChronic corticosteroid use\n\nParticipation in another investigational drug or device study\n\nActive bacterial endocarditis or other active infections",{"count":271,"type":20},[23],"This single-center, non-commercial clinical study investigates how different types of transcatheter aortic valve prostheses affect cerebral oxygen saturation during the procedure (TAVI - Transcatheter Aortic Valve Implantation). The study uses a non-invasive monitoring system (NIRS) to track brain oxygenation (rSO₂) in real time.\n\nThe goal is to understand whether balloon-expandable, intra-annular self-expanding, or supra-annular self-expanding valves lead to different levels or patterns of cerebral oxygenation. This may help identify early warning signs for delayed hemodynamic recovery, stroke, or delirium.\n\nParticipants will be randomly assigned to receive one of:\n\nA balloon-expandable valve (Group A), or\n\nA self-expanding valve (Group B), with further randomization into:\n\nGroup B1: intra-annular valve (NAVITOR)\n\nGroup B2: supra-annular valve (EVOLUT)\n\nThe procedure, follow-up, and data collection will follow standard clinical practice. No experimental devices or drugs are used. Patients will not undergo any additional risk or burden beyond what is normally expected during TAVI.\n\nThe study is being conducted at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy, and aims to enroll 40 patients. No compensation is provided, and participation is voluntary.",[407,26,408,409],"Aortic Stenosis Disease","Cerebral Oxygen Saturation","Hemodynamic Changes",[59,221,408,411,412,413],"NIRS","Balloon-Expandable Valve","Self-Expanding Valve","2025-06-23",{"date":416,"type":31},"2025-06-26",{"date":418,"type":20},"2025-06",{"date":420,"type":20},"2026-06",{"name":422,"class":38},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":21,"phases":433,"briefSummary":434,"conditions":435,"keywords":443,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"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.","85 Years",{"count":432,"type":20},160,[23],"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.",[436,437,110,438,439,440,441,442,26],"Heart Failure","Valvulopathy","Aortic Regurgitation Disease","Mitral Regurgitation","Tricuspid Regurgitation","Brain Natriuretic Peptide","Mitraclip",[436,110,444,439,440,442,445,59],"Aortic Regurgitation","Triclip","2024-10-31",{"date":448,"type":31},"2024-11-04",{"date":450,"type":20},"2025-02-01",{"date":452,"type":20},"2026-02-01",{"name":454,"class":38},"IRCCS Ospedale San Raffaele",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":16,"minAge":461,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":21,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":39},"100516645","phase-4-non-antithrombotic-therapy-after-transcatheter-aortic-valve-implantation-trial-100516645","NCT06007222","Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial","Inclusion Criteria:\n\n1. Patients who underwent transfemoral TAVI for aortic stenosis\n2. Patients aged 20 years or older at the time of informed consent\n3. Patients who have a thorough understanding of the subject of the study and who have agreed in writing to participate in the study\n\nExclusion Criteria:\n\n1. Those with perioperative complications at the time of TAVI (conversion to open heart surgery, coronary artery occlusion, annulus rupture, cardiac tamponade, vascular dissection, cerebral infarction\u002Fcerebral hemorrhage, new atrial fibrillation, new atrioventricular block)\n2. Individuals requiring antiplatelet agents for reasons other than TAVI (history of myocardial infraction, history of PCI（Percutaneous Coronary Intervention）, history of EVT（EndoVascular Treatment）, history of cerebral infraction and transient ischaemic stroke, with significant coronary artery narrowing, with high-grade carotid artery narrowing, and others judged as requiring antiplatelet therapy by the chief researcher or a sub-investigator)\n3. Patients requiring oral anticoagulants (patients with atrial fibrillation, history of pulmonary embolism or deep venous thrombosis, and other patients who are deemed to require anticoagulation therapy by the investigator or coinvestigator)\n4. Patients with eGFR（estimated Glomerular Filtration Rate） \\\u003C30 and patients on hemodialysis\u002Fperitoneal dialysis.\n5. Patients with a history of valve replacement in the heart valves.\n6. Patients who are pregnant, have childbearing potential, wish to become pregnant, or are breastfeeding.\n7. Patients who have a concomitant medical illness associated with expected survival less than one year.\n8. Patients who have the contraindications for aspirin.\n9. Patients with a diagnosis of severe allergy to aspirin or a history of hypersensitivity.\n10. Patients requiring a legally acceptable representative, patients unable to obtain written informed consent, or patients unable to understand the outline or purpose of the study.\n11. Other patients for whom the principal investigator or the coinvestigator judges the participation in the study inappropriate.","20 Years",{"count":463,"type":20},400,[107],"Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg\u002Fday the end of the study period.\n\nNon-antithrombotic group: No antithrombotic agents will be administered after randomization until the end of the study period.",[110,26,467,468,469],"Aspirin","DAPT(Dual Antiplatelet Therapy)","SAPT(Single Antiplatelet Therapy)","2024-09-20",{"date":472,"type":31},"2024-09-23",{"date":474,"type":31},"2023-04-06",{"date":476,"type":20},"2027-12-31",{"name":478,"class":38},"OCEAN-SHD Study Group"]