[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transcatheter-aortic-valve-implantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transcatheter-aortic-valve-implantation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,98,122,156,178,202,232,257,282],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100531262","randomized-study-of-physiological-vs-right-ventricular-pacing-in-patients-with-normal-ventricular-function-post-tavi-100531262",false,"NCT06197503","Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI","Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)","PHYSTAVIII","Inclusion Criteria:\n\n* Successful implantation of TAVI according to VARC-3 criteria.\n* Indication of cardiac pacing due to AV block according to ESC Guidelines.\n* LVEF\\> 50%.\n* The patient must indicate their acceptance to participate in the study by signing an informed consent document.\n\nExclusion Criteria:\n\n* Ventricular dysfunction: LVEF \\\u003C50%.\n* Transapical TAVI.\n* Participating currently in a clinical investigation that includes an active treatment.\n* Patients with left bundle branch block but without indication of pacing (AV block).\n* Life expectancy \\\u003C12 months.","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"NA","Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF\\> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.",[27,28,29,30,31],"Transcatheter Aortic Valve Implantation","Physiological Pacing","Right Ventricular Pacing","AV Block","Preserved Left Ventricular Systolic Function","RECRUITING","2026-03-30",{"date":35,"type":36},"2026-03-31","ACTUAL",{"date":38,"type":36},"2023-11-30",{"date":40,"type":21},"2026-12-15",{"name":42,"class":43},"Hospital Clinic of Barcelona","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":44},"100562395","remote-cardiovascular-monitoring-in-post-tavi-patients-100562395","NCT06602609","Remote Cardiovascular Monitoring in Post-TAVI Patients","Remote Acute Monitoring-based Same-day Discharge Strategy of Post Transcatheter Aortic Valve Implantation Patients Versus Standard Care at 30-Day Follow-up","TELE-TAVI","Inclusion Criteria:\n\n* Patient age must be 18 years or above.\n* Post-TAVI patients without serious complications hindering same-day discharge, including vascular, neurological, and cardiac postprocedural complications necessitating inpatient care:\n* Vascular: Controlled with adequate vascular hemostasis.\n* Neurological: Conscious and oriented, not under the effect of residual sedation.\n* Cardiac: No significant pericardial effusion.\n* Elective non-emergent patient admission and nonelective cases fitting discharge criteria.\n* Comfortable ambulation post-procedure.\n* The patient or their caregiver must have access to a smart device.\n* Ability to provide informed consent (the patient must be alert and oriented for consent).\n* Adequate social support.\n\nExclusion Criteria:\n\n* Hemodynamically unstable post-TAVI condition, periprocedural cardiac arrest, cerebral vascular accident, acute kidney injury (AKI) and major\u002Flife-threatening bleeding requiring blood transfusion.\n* Patients with a permanent (pre-existing or new) implanted pacing device.\n* Procedural failure in device delivery.\n* Major vascular access complications require patients to stay.\n* Inability to engage with the technology.\n* Significant communication barrier.",{"count":54,"type":21},216,[24],"The goal of this randomised clinical trial is to utilise a remote monitoring algorithm to gather essential clinical data, aiming to guide the management of post-Transcatheter Aortic Valve Implantation (TAVI) patients and reduce both postprocedural hospital length of stay and readmissions. This strategic integration of technology aims to address gaps identified in previous studies and enhance the effectiveness of post-TAVI patient care. One significant concern after TAVI is the development of heart conduction abnormalities on the ECG and abnormal rhythms, such as heart block, potentially requiring permanent pacemaker insertion. Addressing these rhythm issues is crucial for reducing the overall length of stay.\n\nThe main question it aims to answer is: Does a remote patient monitoring protocol-driven strategy reduce post-TAVI hospital length of stay and adverse events? Participants post-TAVI procedure and eligible for same-day discharge, as determined by their primary cardiologist, will be randomized upon informed consent into the active arm (remote monitoring) or control group (standard of care).\n\nParticipants in the active arm will: receive four remote monitoring devices. Receive support from a validated clinical decision-making algorithm for further management.\n\nParticipants in the control group will: adhere to the best standard of care as per current practice.\n\nResearchers will compare the active arm to the control group to see if the remote patient monitoring protocol-driven strategy reduces post-TAVI hospital length of stay and adverse events.",[58,59,60,27,61],"Aortic Valve Stenosis","Cardiac Conduction Disturbance","Digital Health","TAVI",[63,64,65,66,67,60,68,61,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"POST-TAVI","Hospital Length of Stay","Same-Day Discharge","Remote Monitoring","Ambulatory ECG","Valvular Heart Disease","TAVR","Medical Device","Hospital at Home","Home Health","Telemedicine","Virtual Health","ECG","EKG","RCT","Digital Innovation","Technology","Ambulatory","Cardiology","Post-Acute","Post Acute","Digital Technology","Electrocardiogram","Clinical Trials","Telehealth","Home Telemetry","2026-02-27",{"date":91,"type":36},"2026-03-03",{"date":93,"type":36},"2024-11-01",{"date":95,"type":21},"2028-07-01",{"name":97,"class":43},"Imperial College London",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":44},"100575553","transcatheter-aortic-valve-implantation-comparison-of-the-effects-of-ultrasound-guided-pericapsular-nerve-group-block-and-fascia-iliaca-block-on-postoperative-analgesia-management-100575553","NCT06773780","Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management","Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management - A Randomized, Prospective Study","Inclusion Criteria:\n\n* Patients scheduled for TAVİ\n* aged between 18 and 85 years,\n* American Society of Anesthesiology (ASA) physical status II-IV\n\nExclusion Criteria:\n\n* History of bleeding diathesis.\n* Use of anticoagulant therapy.\n* History of chronic pain prior to surgery.\n* Multiple trauma.\n* Conditions where pain assessment cannot be performed (e.g., dementia).\n* Patients operated under spinal or epidural anesthesia.\n* Presence of infection in the region where the block will be applied.\n* Refusal to consent to the procedure","85 Years",{"count":107,"type":21},60,[24],"Aortic Stenosis (AS) is the most common valvular pathology, particularly prevalent in advanced age, and Transcatheter Aortic Valve Implantation (TAVI) has become a crucial treatment option for high-risk patients who are not suitable for surgery. This minimally invasive approach has demonstrated successful clinical outcomes in patients deemed ineligible for surgical procedures.\n\nPatient selection criteria and advancements in operative techniques are critical for achieving successful TAVI outcomes. While the transfemoral approach is the most commonly used method, alternative techniques such as transapical, transaxillary, transcarotid, and transaortic approaches are also available.\n\nThe Pericapsular Nerve Group Block (PENG) targets the femoral and accessory obturator nerves, providing analgesia to the anterior hip without causing motor block. The Fascia Iliaca Block (FIB), on the other hand, provides broader analgesic coverage by affecting the lateral femoral cutaneous, obturator, and femoral nerves.\n\nThis study aims to compare PENG block, FIB, and local infiltration anesthesia in TAVI patients regarding sedation requirements during the procedure and postoperative analgesia management. Additionally, pain scores, motor block presence, opioid consumption, and side effects will be assessed. The study seeks to identify optimal strategies to enhance patient comfort and safety during TAVI procedures.",[58,27,111,112],"Pericapsular Nerve Group Block","Fascia Iliaca Block","2025-12-01",{"date":115,"type":36},"2025-12-02",{"date":117,"type":36},"2025-01-10",{"date":119,"type":21},"2026-12-01",{"name":121,"class":43},"Medipol University",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":141,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":44},"100584966","tavr-the-impact-of-prothesis-positioning-on-valvular-and-coronary-hemodynamics-100584966","NCT06896227","TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics","Transcatheter Aortic Valve Implantation (TAVR): The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics","Inclusion Criteria\n\n\\- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).\n\nExclusion Criteria\n\n* Any access route other than transfemoral.\n* Valve-in-valve procedures.\n* History of prior bioprosthetic valve implantation.\n* Presence of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) system.\n* Diagnosis of liver cirrhosis.\n* Esophageal disorders, including but not limited to esophageal varices.\n* Thrombocytopenia or coagulation disorders.\n* Any medical or psychiatric condition (e.g., dementia, alcoholism, or substance abuse) that may impair the ability to provide informed consent or interfere with study procedures, including follow-up visits.",{"count":130,"type":21},100,[24],"The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries.\n\nThe main questions it aims to answer are:\n\n1. Does the cardiac magnetic resonance imaging and the echocardiography imaging provide an equivalent alternative to the computer tomography which is the state of the art in evaluating commissural alignment?\n2. What effect does the position of the valve on the annular level have, especially its symmetrical and commissural position, on valvular and aortic blood flow characteristics?\n3. What is the influence of symmetrical position and the presence of a commissural alignment on the coronary flow after transcatheter aortic valve replacement?",[134,27,135,136,137,138,139,58,140],"Transcatheter Aortic Valve Replacement","Commissural Alignment","Commissural Misalignment","Symmetry","Prothesis Positioning","Prosthesis Durability","Aortic Valve Disease",[69,61,142,137,143,144,145,146],"Commissural alignment","Prothesis positioning","cMRI","4D Flow","TEE","2025-03-19",{"date":149,"type":36},"2025-03-26",{"date":151,"type":36},"2024-10-22",{"date":153,"type":21},"2025-12-31",{"name":155,"class":43},"Heinrich-Heine University, Duesseldorf",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":163,"targetDuration":165,"studyType":166,"phases":4,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":44},"100192205","registry-of-aortic-valve-bioprostheses-established-by-catheter-100192205","NCT01777828","Registry of Aortic Valve Bioprostheses Established by Catheter","FRANCE-TAVI","Inclusion Criteria: Patients who have undergone transarterial or transapical aortic valve bioprosthesis implantation\n\nExclusion Criteria: Patient has not given consent",{"count":164,"type":21},5000,"10 Years","OBSERVATIONAL","The aim of this registry is to evaluate the overall survival up to 10 years of patients with aortic valve bioprostheses implanted via the transarterial or transapical route. Data from the register is enhanced by matching it with continuous data in the SNDS.\n\nMandated by the French health authorities, this registry must be maintained as part of the management of any patient undergoing transarterial or transapical aortic valve bioprosthesis implantation.\n\nParticipation in the registry is offered to all subjects eligible for bioprosthesis implantation.",[27],"2025-02-12",{"date":171,"type":36},"2025-02-14",{"date":173,"type":36},"2013-02",{"date":175,"type":21},"2034-02",{"name":177,"class":43},"French Cardiology Society",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":199,"locationsCount":201},"100530683","rapid-atrial-pacing-after-tavi-to-predict-pacemaker-implantation-100530683","NCT06189976","Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation","Rapid Atrial Pacing After TAVI as a Predictor of Permanent Pacemaker Implantation","Inclusion Criteria:\n\n1. Adults ≥18 years old.\n2. Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.\n3. Patient has given written consent to participate in the trial.\n4. Patients undergoing TAVI as a treatment of severe aortic stenosis (AS).\n5. Patient in sinus rhythm.\n6. Patients planned for TAVI with utilization of temporary pacemaker electrode placement.\n\nExclusion Criteria:\n\n1. Ongoing infection, including active endocarditis.\n2. Implanted permanent pacemaker and\u002For implantable cardioverter\u002Fdefibrillator.\n3. Patients developing persistent second or third degree atrioventricular block (AV) after TAVI.\n4. Underlying rhythm other than sinus based on the surface ECG leads monitoring after TAVI.\n5. Patients with second or third degree AV block identifyied on the screening pre-TAVI ECG.\n6. Enrolment in another study that competes or interferes with this study.\n7. Subject will not be able to comply with the follow-up requirements according to investigators' opinion.\n8. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study.",{"count":186,"type":21},400,[24],"Despite Transcatheter aortic valve implantation (TAVI) evolution regarding techniques, equipment and experience, the need for permanent pacemaker implantation (PPI) post-TAVI remains an important drawback. The electrophysiology testing to stratify the risk or necessity of PPI post-TAVI is endorsed by the up-to-date guidelines and consensus documents and it is a valuable cut-off based method. Part of the answer is maybe hidden in the easy and applicable testing of the atrioventricular conduction system through rapid atrial pacing (RAP) with a common temporary pacemaker lead. This trial is designed to investigate the role and value of RAP after TAVI as a predictor of the necessity of new PPI.",[140,27,61],[69,61,191,192],"Rapid atrial pacing","Aortic stenosis","2024-12-09",{"date":195,"type":36},"2024-12-12",{"date":197,"type":36},"2024-03-01",{"date":153,"type":21},{"name":200,"class":43},"National and Kapodistrian University of Athens",2,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":44},"100449543","complete-functional-assessment-of-intermediate-coronary-artery-stenosis-before-and-after-transcatheter-aortic-valve-implantation-tavi-in-patients-with-severe-symptomatic-aortic-valve-stenosis-100449543","NCT05133843","Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis","CHOICE-FR","Inclusion Criteria:\n\n* Age \\>18 years\n* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure\n* Severe symptomatic aortic stenosis with indication for TAVI according to current guidelines deemed by the Heart Team\n* Patients who have undergone coronary CT angiography before TAVI in which CAD could not be ruled out\n* CAD in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed coronary stenosis, in which the physiological severity of the lesion is in question (typically 40-90% diameter stenosis).\n* Eligible for invasive coronary angiography and functional assessment (FFR, RFR, CFR and IMR)\n* Eligible for coronary CT-angiography and functional assessment (CT-FFR)\n\nExclusion Criteria:\n\n* Patients whose CT-angiography was determined to be non-diagnostic\u002Funreadable during its evaluation\n* Previous coronary artery bypass grafting with patent grafts to the interrogated vessel\n* Patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis\n* Critical coronary artery disease deemed by the Heart Team to require immediate revascularization\n* Contraindication to adenosine (e.g. bronchial asthma)\n* Chronic renal impairment with severe reduction of glomerular filtration rate (eGFR \\\u003C30 ml\u002Fmin)\n* Presence of cardiogenic shock\n* Participation in another interventional study involving the left heart or coronary arteries",{"count":210,"type":21},50,[24],"The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.",[214,27],"Coronary Artery Stenosis",[214,216,217,218,219,220,221,222],"transcatheter aortic valve implantation","coronary physiology","coronary blood flow","coronary microcirculatory function","non-invasive CT-FFR","fractional flow reserve","resting full cycle ratio","2024-11-22",{"date":225,"type":36},"2024-11-25",{"date":227,"type":36},"2021-09-29",{"date":229,"type":21},"2025-09-30",{"name":231,"class":43},"Helios Health Institute GmbH",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":44},"100553057","reversibility-of-cardiac-conduction-disturbances-following-tavi-100553057","NCT06481137","Reversibility of Cardiac Conduction Disturbances Following TAVI","InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study","TAVI-REVERSE","Inclusion Criteria:\n\n* Patients with indication for electrophysiological (EP) study after TAVI implantation according to European Guidelines. Patients must have persistent electrocardiographic conduction disturbances (ECG-CDs) that are present from day 2 after TAVI implantation (≥ 48h post-procedure):\n* De novo LBBB with QRS complex \\>150ms and\u002For PR interval ≥240ms.\n* QRS widening or post-procedural PR lengthening \\> 20ms in patients with baseline ECG-CDs.\n\nExclusion Criteria:\n\n* Patients with previous pacemaker or implantable defibrillator.\n* Patients with baseline complete right bundle branch block.\n* Patients in need of cardiac resynchronization or physiological stimulation following TAVI.\n* Valve-in-valve procedures.\n* TAVI procedures in patients with severe aortic insufficiency.\n* Inability to sign the informed consent form.",{"count":241,"type":21},209,[24],"The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block.\n\nIn this study, the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study (EPS) 3-7 days following TAVI. In addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI.\n\nIn this multicenter, longitudinal, prospective study, patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included. A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days. Additionally, these patients will undergo 4-week continuous monitoring using the ePatch (Philips) long-term Holter recorder, to identify episodes of paroxysmal complete atrioventricular block. Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks.",[245,27,246],"Aortic Stenosis","Conduction Disturbances",[192,27,246],"2024-06-25",{"date":250,"type":36},"2024-07-01",{"date":252,"type":36},"2024-06-17",{"date":254,"type":21},"2026-12-31",{"name":256,"class":43},"Institut d'Investigació Biomèdica de Bellvitge",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":272,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":44},"100508030","conventional-versus-left-bundle-branch-pacing-in-tavi-100508030","NCT05895097","Conventional Versus Left Bundle Branch Pacing in TAVI","Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation","Inclusion Criteria:\n\n* Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)\n* Left ventricular ejection fraction \\\u003C 50 %.\n\nExclusion Criteria:\n\n* Unsuccessful TAVI procedure with life expectancy \\\u003C 1 year\n* Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)\n* Severe kidney failure (glomerular filtration rate \\\u003C 30 ml\u002Fmin)\n* Previous permanent pacemaker",{"count":210,"type":21},[24],"This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \\\u003C 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (\\\u003C 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).",[58,268,269,27],"Heart Failure","Pacemaker-Induced Cardiomyopathy",[27,271],"Left bundle branch pacing","NOT_YET_RECRUITING","2023-06-05",{"date":275,"type":36},"2023-06-08",{"date":277,"type":21},"2023-06-15",{"date":279,"type":21},"2026-06-15",{"name":281,"class":43},"University Medical Centre Ljubljana",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":289,"targetDuration":290,"studyType":166,"phases":4,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":272,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":298,"leadSponsor":300,"locationsCount":4},"100479840","safety-and-efficacy-of-emergent-tavi-in-patients-with-severe-as-100479840","NCT05528211","Safety and Efficacy of Emergent TAVI in Patients With Severe AS","Safety and Efficacy of Emergent Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Aortic Valve Stenosis (AS): a Single-center, Prospective, Observational Cohort Study.","Inclusion Criteria:\n\n1. Every patient that diagnosed with severe aortic valve stenosis (evaluated by echocardiography: peak transaortic valve blood flow rate ≥4.0m\u002Fs, or mean transaortic valve pressure gradient ≥40mmHg (≥5.32kPa), or aortic Valve area \\\u003C0.8cm2, or AVA\\\u003C0.5cm2\u002Fm2);\n2. Every patient that 1) required cardiopulmonary resuscitation due to cardiac arrest, or requiring external chest compressions during surgery (Salvage), 2) or has ongoing, refractory (difficult, complicated, and\u002For unmanageable) unrelenting cardiac compromise, with or without hemodynamic instability, and not responsive to any form of therapy except cardiac surgery (STS\u002FACC TVT defined \"Urgent Status\"), 3) or required urgent procedure during same hospitalization in order to minimize chance of further clinical deterioration (examples include, but are not limited to, worsening, sudden chest pain, heart failure, acute myocardial infarction, anatomy, intra-aortic balloon pump, unstable angina with intravenous nitroglycerin or rest angina) (STS\u002FACC TVT defined \"Urgent Status\");\n3. Every patient that has been informed of the objectives of the study, agreed to participate, has signed the approved consent form, and was willing to accept all relevant examinations and clinical follow-up.\n\nExclusion Criteria:\n\n1. Anatomically, the approach or aortic root is not suitable for transcatheter aortic valve implantation (TAVI).\n2. Anatomical morphology or vascular diseases affecting the device approach.\n3. Left ventricular outflow tract obstruction.\n4. Primary dilated cardiomyopathy.\n5. The echocardiogram indicates the presence of left ventricular thrombus.\n6. Cannot tolerate anticoagulation and antiplatelet therapy.\n7. Are allergic or resistant to nickel titanium alloys.\n8. Active infective endocarditis, or other active infections affecting the effect of TAVI.\n9. Severe disabling Alzheimer's disease.\n10. Life expectancy\\\u003C 6 months.\n11. Other conditions (examples include poor compliance of patients and families) considered by the investigator to be inappropriate for participation in this clinical trial.",{"count":5,"type":21},"5 Years","This is a single-centre, prospective, observational cohort study focusing on of patients suffering severe aortic valve stenosis (AS) undergoing emergent transcatheter aortic valve implantation (TAVI). AS patients undergoing emergent TAVI always have complicated clinical situations. Therefore, the aims of the study are to collect the incidence and outcomes of emergent TAVI in patients with severe symptomatic AS, to assess the safety and effectiveness of emergency TAVI system for severe AS, and to describe a more practical evidence of emergency TAVI system in severe AS patients.",[58,27,293],"Emergencies","2022-09-01",{"date":296,"type":36},"2022-09-06",{"date":294,"type":21},{"date":299,"type":21},"2028-11-01",{"name":301,"class":43},"Qilu Hospital of Shandong University"]