[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-stenosis-treated-with-tavi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-stenosis-treated-with-tavi":142},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,38,67,99,126],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100643843","the-shortcut-post-market-study-100643843",false,"NCT07631988","The ShortCut Post-Market Study","A Prospective, Multicenter, Non-Randomized, Single-Arm, Post-Market Study of the ShortCut™ (The ShortCut PMS)","ShortCut PMS","Inclusion Criteria:\n\n1. Male or female ≥ 22 years of age.\n2. Subject is planned to undergo a ViV TAVR procedure with the ShortCut, according to its labeling.\n3. Preprocedural evidence for risk for coronary occlusion during ViV TAVR in bioprosthetic valve failure.\n4. Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations\n\nExclusion Criteria:\n\n1. Any contraindication as specified in the approved device label.\n2. An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.\n3. Anatomy that is not suitable for the use of the ShortCut, as determined by CT assessment.\n4. Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure.\n5. Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure or severe neurological disability, as determined by the investigator.\n6. Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.\n7. Hemodynamic or respiratory instability.\n8. Left ventricle ejection fraction \\\u003C 30%.\n9. Ongoing severe infection, sepsis or endocarditis.\n10. Patient has renal insufficiency (GFR \\\u003C 30 ml\u002Fmin or serum creatinine \\> 2.5 mg\u002FdL), or on chronic dialysis.\n11. Need for emergency surgery for any reason.\n12. Life expectancy is less than 1 year.","ALL","22 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for subjects at risk for coronary obstruction. The ShortCut has been cleared by FDA under DEN240017, and this study is a post-market evaluation of the ShortCut per the FDA cleared indications for use.\n\nThe objectives of the study are:\n\n1. To collect real-world data on the use of ShortCut to split bioprosthetic aortic valve leaflets prior to TAVR in subjects at risk for coronary obstruction.\n2. To collect real-world data on coronary patency following ShortCut and ViV TAVR procedures in subjects who are at risk for coronary artery ostium obstruction.\n\nData will be collected, where available, from the subjects' medical records at the following time-points: baseline, index procedure, pre-discharge, and 30 days post-procedure.",[25],"Aortic Stenosis Treated With TAVI","NOT_YET_RECRUITING","2026-06-03",{"date":29,"type":30},"2026-06-08","ACTUAL",{"date":32,"type":21},"2026-06",{"date":34,"type":21},"2027-09",{"name":36,"class":37},"Pi-cardia","INDUSTRY",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":17,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100623109","zhicheng-tavr-robot-100623109","NCT07392359","Zhicheng TAVR Robot","Prospective, Multicentre, Randomised Controlled, Non-Inferiority Clinical Trial Evaluating the Safety and Efficacy of the TAVR Assist System and Its Disposable Kit for Use as an Adjunct to TAVR","Inclusion Criteria:\n\n* Age ≥65 years old, gender is not limited;\n* Patients assessed by a cardiac multidisciplinary team (MDT) expert panel as having severe aortic stenosis and suitable for transcatheter aortic valve replacement;\n\n  \\*Severe aortic stenosis was defined as echocardiographically demonstrated transaortic valve flow velocity ≥4.0 m\u002Fs, or transaortic valve pressure differential ≥40 mmHg (1 mmHg=0.133 kPa), or aortic orifice area \\\u003C1.0 cm2, or effective aortic orifice area index \\\u003C0.6 cm2\u002Fm2; for low-pressure-differential-low-flow rate by dopa-phenobutylamine loading test, Doppler ultrasound evaluation or other imaging means of assessment for those judged to have severe aortic stenosis.\n* Have a core laboratory assessment that the patient is anatomically suitable for transcatheter aortic valve replacement;\n* Patients who understand the purpose of the trial, voluntarily participate in the trial, sign an informed consent form, and are willing to cooperate in the follow-up.\n\nExclusion Criteria:\n\n* Patients whose access or aortic root anatomical pattern is unsuitable for TAVR treatment;\n* Poor peripheral arterial conditions that preclude transfemoral TAVR;\n* Aortic annulus horizontal pinch angle ≥65° as measured by preoperative MDCT;\n* Patients at high risk of coronary obstruction requiring intraoperative coronary protection measures;\n* Patients requiring intraoperative delivery with a grapple assist system;\n* Previous implantation of a prosthetic aortic valve (bioprosthetic or mechanical);\n* Active stage of infective endocarditis or other active infection;\n* Combined mitral, tricuspid or severe macrovascular lesions requiring surgical or interventional intervention;\n* Echocardiography suggestive of left ventricular thrombus, intracardiac mass or redundant organisms;\n* Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathy (e.g. amyloidosis, haemochromatosis, nodular disease, etc.), constrictive pericarditis;\n* Severe obstruction of the left ventricular outflow tract without corrective measures;\n* Severe pulmonary hypertension (pulmonary artery systolic pressure \\>70 mmHg measured by ultrasound);\n* Severe right heart dysfunction as suggested by a combined clinical and ultrasound assessment;\n* Severe left heart systolic insufficiency (left ventricular ejection fraction \\\u003C30%);\n* Cardiogenic shock or haemodynamic instability requiring ventricular assist device therapy within 30 days prior to enrolment;\n* End-stage heart failure (ACC\u002FAHA Stage D), or post cardiac transplantation, or awaiting cardiac transplantation;\n* Acute myocardial infarction within 30 days prior to enrolment;\n* Has had a stroke within 3 months prior to enrolment;\n* Stenosis of the common or internal carotid artery or vertebral artery (\\>70% stenosis) requiring treatment as recommended by the relevant disciplinary consultation;\n* Severe cardiac and aortic disease requiring concomitant treatment, including ascending aortic aneurysm (maximum diameter ≥ 50 mm);\n* Severe renal insufficiency (estimated glomerular filtration rate \\\u003C30mL\u002Fmin\u002F1.73m2);\n* Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months prior to enrolment;\n* Severe coagulopathy; Patients with known intolerance to anticoagulant, antiplatelet drugs or anaesthetic drugs; Patients who have participated in other drug or medical device clinical trials prior to enrolment that have not met the primary endpoint; Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial",true,"65 Years","100 Years",{"count":49,"type":21},158,"INTERVENTIONAL",[52],"NA","Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit for Use as an Adjunct to Transcatheter Aortic Valve Replacement",[25],[56,57],"TAVR Assist System","Aortic stenosis treated with TAVI","2026-01-29",{"date":60,"type":30},"2026-02-06",{"date":62,"type":21},"2026-02-15",{"date":64,"type":21},"2026-10-15",{"name":66,"class":37},"Zhicheng Medical Technology (Jiaxing) Co, Ltd",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":50,"phases":78,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100569099","trial-of-the-f2-filter-and-delivery-system-for-embolic-protection-during-tavr-100569099","NCT06689839","Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR","A Prospective, Randomized, Multicenter, Single-blind Trial to Assess the Safety and Effectiveness of the Encompass F2 Cerebral Protection System Vs. Standard of Care (Unprotected or Sentinel® Cerebral Protection System) During Transfemoral Transcatheter Aortic Valve Replacement","SHIELD","Key Inclusion Criteria:\n\n* Age ≥ 50 years.\n* Patient meets the established criteria and indications for commercially available TAVR via transfemoral access and is scheduled to undergo TAVR per their treating physician.\n* Patient is willing and able to comply with protocol-specified follow-up evaluations.\n* Patient is able and willing to provide written informed consent.\n* Patient meets all criteria for use of control device (Sentinel device, per IFU).\n\nKey Exclusion Criteria:\n\nGeneral Exclusion Criteria:\n\n* Patient requires an urgent or emergent TAVR procedure.\n* Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure or planned within 30 days post-TAVR procedure.\n* Diagnostic cardiac catheterization within 10 days prior to TAVR procedure.\n* Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.\n* Prior prosthetic heart valve in any position.\n* Known intracardiac thrombus.\n* Active infection or endocarditis.\n* Patient is contraindicated for anti-platelet and\u002For anticoagulant therapy.\n* Patient refuses blood transfusion.\n* Renal insufficiency (creatinine \\> 2.5 mg\u002FdL or GFR \\\u003C 30) and\u002For renal replacement therapy at the time of screening.\n* Patients with hepatic failure (Child-Pugh class C).\n* Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C 30%.\n* Females who are pregnant or nursing or plan to become pregnant during their participation in the study.\n\nNeurological Exclusion Criteria:\n\n* Modified Rankin Scale (mRS) ≥ 2 at screening.\n* Cerebrovascular event including TIA within 6 months of the procedure.\n* Patient has active major psychiatric disease, known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.\n* Patient has severe visual, auditory, or learning impairment.\n* Patient has neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.\n\nMagnetic Resonance Imaging Exclusion Criteria:\n\n* Contraindications to MRI (participants with MR unsafe implants including implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).\n* High risk of complete AV block after TAVR, with the need of permanent pacemaker.\n* Claustrophobia precluding MRI scanning.\n\nAnatomical and CT Exclusion Criteria:\n\n* Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath, vascular access or filter deployment.\n* Presence of cardiovascular implant in aorta and\u002For peripheral access vessels.\n* Access vessels with excessive tortuosity.\n* Aortic arch, which is heavily calcified, severely atheromatous, or severely tortuous.","50 Years",{"count":77,"type":21},500,[52],"The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)",[25,81],"Aortic Diseases",[83,84,85,86,87],"Embolic Protection","Transcatheter Aortic Valve Replacement","TAVR","Aortic Valve Stenosis","Aortic Valve Diseases","RECRUITING","2025-11-19",{"date":91,"type":30},"2025-11-20",{"date":93,"type":30},"2025-09-09",{"date":95,"type":21},"2027-01",{"name":97,"class":37},"EnCompass Technologies, Inc.",10,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":50,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100597533","high-flow-nasal-oxygenation-in-transcatheter-aortic-valve-replacement-procedures-tavr-highflow-ii-100597533","NCT07059728","High Flow Nasal Oxygenation in Transcatheter Aortic Valve Replacement Procedures. TAVR-Highflow II","Uso de Lentillas de Alto Flujo en Procedimientos de sustitución de válvula aórtica transcatéter. Impacto en Las Complicaciones Respiratorias y Biomarcado- Res y Resultados clínicos. TAVR-Highflow","Inclusion Criteria:\n\n* Transfemoral TAVR elective procedure\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Refusal to participate\n* Known allergy to propofol or remifentanil.\n* Non-femoral surgical access.\n* Presence of a basal skull fracture or pneumothorax\n* Procedure duration \\\u003C 45 minutes\n* Previously planned general anaesthesia approach due to patient's condition or procedural technical reasons\n* Need to convert to general anesthesia for non-respiratory complications within 45 minutes.","18 Years",{"count":108,"type":21},452,[52],"Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with aortic valve disease. TAVR is a less invasive treatment compared to the conventional surgical approach through median sternotomy.\n\nPatients selected for this procedure often have a profile associated with multiple comorbidities which predispose them to certain complications.\n\nTAVI procedures were initially performed under general anesthesia. However, due to improved procedure times and anesthetic techniques, sedation has become the current trend to preform them.\n\nWhen sedation for these procedures requires deep planes, hypoxia is more likely to occur due to respiratory depression, apnea, or airway obstruction. This is even more common in TAVR patients population, as obesity, sleep apnea, elevated ASA classification, advanced age, and combined cardiorespiratory disease are highly prevalent.\n\nFor all these reasons, TAVR constitutes a risky procedure, presenting a profile of patients undergoing this procedure that can also be considered high risk.\n\nThe provision of supplemental oxygen through nasal cannulae or face masks can prevent the development of hypoxia. Unfortunately, non-humidified nasal oxygen cannot exceed 2-5 L\u002Fmin without causing damage to the nasal mucosa, and the percentage of oxygen delivered through variable-flow face masks is unpredictable.\n\nOn the other hand, high-flow nasal oxygen therapy (HFNO) can provide humidified gas flow rates of up to 70 L\u002Fmin through specially adapted nasal cannulae and reliably deliver oxygen concentrations between 21% and 100%. The use of HFNC could be justified in this context and could improve the outcomes and safety of these procedures, increasing oxygen content and minimizing hypercapnia.\n\nThe study's hypothesis is HFNO will prevent hypoxemia and control hypercapnia during sedation for transcatheter aortic valve implantation (TAVI) better than conventional oxygen theraphy. Clinical and serological biomarkers of tissue injury will decrease with the use of HFNO. Clinical complications will decrease with the use of HFNO.\n\nThe study population would be all patients \\>18 years of age undergoing TAVI procedure and who agree to participate in the study in 8 centers in Barcelona.",[25,112],"Sedation; Aged; Hemodynamics",[114,85,115],"Aortic Stenosis","Sedation",{"date":117,"type":30},"2025-09-15",{"date":119,"type":30},"2025-02-01",{"date":121,"type":21},"2027-07",{"name":123,"class":124},"Hospital Clinic of Barcelona","OTHER",1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":134,"targetDuration":136,"studyType":22,"phases":4,"briefSummary":137,"conditions":138,"keywords":143,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":125},"100574207","one-year-pacing-dependency-after-tavr-100574207","NCT06756282","One Year Pacing Dependency After TAVR","Pacing Dependence at 1 Year Follow-up in Patients Implanted With a Pacemaker After TAVR: a Multicenter Observational Study.","PACETAVI","Inclusion Criteria:\n\nall patients who need a permanent pacemaker implantation after TAVR\n\nExclusion Criteria:\n\nPatients who have already a pace maker before TAVR",{"count":135,"type":21},90,"12 Months","Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and two-thirds of patients who required a permanent pace maker implantation post TAVR were not found to be dependent at subsequent follow-up. This study aims to evaluate a cohort of patients permanently implanted with a pacemaker post-TAVR for high-grade conductive disorders and to describe the prevalence of effective pacemaker stimulation at 1 year follow-up. Secondary objectives include the evaluation of the prevalence of effective stimulation 3 months after implantation of the pace maker , description of the types of conductive disorders associated with atrial and\u002For ventricular stimulation, description of the initial indication for pacemaker implantation, description of the characteristics of the population with or without stimulation dependency. The objective is to better rationalize indication of permanent stimulation after TAVI",[139,140,141,142],"Patients Above 18 Years","Patient Discharge","Pacing Therapy","Aortic Stenosis (Treated With TAVI)",[144,145,146,147],"transcatheter aortic valve replacement (TAVR)","permanent pacing","conductive disorders","pacing dependency","2025-01-02",{"date":150,"type":30},"2025-01-03",{"date":152,"type":30},"2024-11-13",{"date":154,"type":21},"2027-10-13",{"name":156,"class":124},"University Hospital, Montpellier"]