[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632120":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":49,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":66,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Istanbul Mehmet Akif Ersoy Educational and Training Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TAVI",null,"Patient with severe aortic stenosis who are clinical candidates for TAVI based on multidisciplinary heart team evaluation.",[13],"Procedure: Transcatheter aortic valve replacement (TAVR \u002F TAVI)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Transcatheter aortic valve replacement (TAVR \u002F TAVI)","TAVI is performed as per standard procedural guidelines",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Serkan Aslan, Ass. Prof MD","CONTACT","+90(212) 692 20 00","drserkanaslan@gmail.com",{"name":27,"role":23,"phone":24,"phoneExt":10,"email":28},"Ahmet Tas, MD PhD","ahmettas.cor@gmail.com",[30],{"facility":5,"status":10,"city":31,"state":10,"zip":10,"country":32,"countryCode":10,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Istanbul","Turkey (Türkiye)",{"type":34,"coordinates":35},"Point",[36,37],28.94966,41.01384,{"lat":37,"lon":36},[40,43,44,46],{"name":41,"role":42,"phone":10,"phoneExt":10,"email":10},"Serkan Aslan, Ass Prof MD","PRINCIPAL_INVESTIGATOR",{"name":27,"role":42,"phone":10,"phoneExt":10,"email":10},{"name":45,"role":42,"phone":10,"phoneExt":10,"email":10},"Mehmet Erturk, Prof MD",{"name":47,"role":48,"phone":10,"phoneExt":10,"email":10},"Gonca Donmez, MD","SUB_INVESTIGATOR",{"type":42,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Serkan Aslan","Ass. Prof","100632120","pressure-based-evaluation-of-disease-improvement-in-the-course-of-tavi-100632120",false,"NCT07509554","PRessure-based Evaluation of Disease Improvement in the Course of TAVI","Investigation of the Relationship Between Changes in Modern Wave-Based Hemodynamic Metrics and Procedural Success or Clinical Improvement in Patients With Severe Aortic Stenosis Following Transcatheter Aortic Valve Replacement (TAVR)","PREDIC-TAVI","Inclusion Criteria:\n\n* Age 60-90 years.\n\nConfirmed diagnosis of severe Aortic Stenosis (AS) and a confirmed guideline-based indication for Transcatheter Aortic Valve Implantation (TAVI) by a multidisciplinary Heart Team, in accordance with the latest ESC\u002FEACTS guidelines.\n\n(In the presence of Vmax ≥ 4.0 m\u002Fs, Mean Gradient ≥ 40 mmHg, or AVA ≤ 1.0 cm²; applicable primarily to all symptomatic patients, adopting a proactive approach regarding age limits and risk profiles. Guidelines recommend TAVI as the first-line therapy \\[Class I\\] for all patients aged 70 and older with anatomical suitability and a tricuspid valve structure, regardless of surgical risk. For patients under 70, TAVI is recommended when surgical risk is high or surgery is deemed unsuitable. In asymptomatic individuals, a decline in left ventricular ejection fraction \\[LVEF\\] below 55% \\[not attributable to other causes\\] constitutes a Class I indication for intervention. Early intervention \\[Class IIa\\] is considered for patients with preserved EF but high-risk markers such as very severe stenosis \\[Vmax \\> 5.0 m\u002Fs\\], rapid progression \\[increase \\> 0.3 m\u002Fs\u002Fyear\\], significant NT-proBNP elevation \\[\\> 3 times the upper limit of normal\\], or severe pulmonary hypertension. In cases of low-flow, low-gradient \\[LFLG\\] AS, the indication for TAVI arises if true-severe stenosis is confirmed via dobutamine stress echocardiography or CT calcium scoring \\[Male ≥ 2000, Female ≥ 1200\\]. All treatment decisions are finalized by a multidisciplinary Heart Team assessing anatomy, frailty, and patient preferences.)\n\nWritten informed consent.\n\nExclusion Criteria:\n\n* Active infection, uncontrolled systemic disease, active malignancy, or life expectancy \\\u003C 1 month.\n\nPregnant or lactating patients.\n\nPressure tracings with significant artifacts hindering analysis or uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response).\n\nAny other condition deemed clinically unsuitable by the investigator.","ALL","60 Years","90 Years",{"count":64,"type":65},100,"ESTIMATED","1 Year","OBSERVATIONAL","The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90) with severe Aortic Stenosis who are undergoing Transcatheter Aortic Valve Replacement (TAVR\u002FTAVI).\n\nThe main questions it aims to answer are:\n\nDo changes in heart pressure wave patterns immediately after the new valve is implanted relate to improvements in a patient's quality of life and heart health over the following year?\n\nCan these advanced wave measurements better predict major heart complications (MACE) at 30 days, 180 days and 1 year compared to standard clinical tests?\n\nParticipants will:\n\nUndergo a standard TAVR (TAVI) procedure as part of their regular medical care to replace a narrowed heart valve.\n\nHave their aortic pressure waves recorded through a catheter during the routine procedure (this happens during the surgery and does not require any additional incisions or invasive steps).\n\nComplete quality-of-life surveys (EQ-5D-5L) and clinical assessments before the procedure.\n\nBe followed up via telephone calls or electronic health records at 30 days, 180 days and 12 months after the procedure to check on their recovery and overall health status.",[70],"Aortic Stenosis",[9,72,73,74,75],"TAVR","AORTIC STENOSIS","wave intensity analysis","reservoir excess pressure analysis","NOT_YET_RECRUITING","2026-03-29",{"date":79,"type":80},"2026-04-03","ACTUAL",{"date":82,"type":65},"2026-03-30",{"date":84,"type":65},"2029-08",{"name":5,"class":6},1]