[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tavi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tavi":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,48,105,129,163,195,221,243,270],{"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":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100617375","phase-4-echo-guided-vs-fluoroscopy-guided-transcatheter-aortic-valve-replacement-in-patients-with-aortic-stenosisecho-tavr-100617375",false,"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.","ALL","65 Years",{"count":20,"type":21},212,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Aortic Stenosis","TAVI","TAVI(Transcatheter Aortic Valve Implantation)",[31,32,29,28,27,33,34],"Ultrasound-guided","Percutaneous Intervention","PAN Procedure","non fluoroscopic","NOT_YET_RECRUITING","2026-04-16",{"date":38,"type":39},"2026-04-21","ACTUAL",{"date":41,"type":21},"2026-04-26",{"date":43,"type":21},"2028-07-31",{"name":45,"class":46},"China National Center for Cardiovascular Diseases","OTHER_GOV",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":47},"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.","18 Years",{"count":58,"type":21},216,[60],"NA","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.",[63,64,65,66,28],"Aortic Valve Stenosis","Cardiac Conduction Disturbance","Digital Health","Transcatheter Aortic Valve Implantation",[68,69,70,71,72,65,73,28,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"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","RECRUITING","2026-02-27",{"date":97,"type":39},"2026-03-03",{"date":99,"type":39},"2024-11-01",{"date":101,"type":21},"2028-07-01",{"name":103,"class":104},"Imperial College London","OTHER",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":47},"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":113,"type":21},40,"OBSERVATIONAL","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.",[27,117,118,28,29],"Gut Microbiome","Gut Microbiota",[28],"2025-11-14",{"date":122,"type":39},"2025-11-18",{"date":124,"type":39},"2025-09-01",{"date":126,"type":21},"2027-11-01",{"name":128,"class":104},"Hippocration General Hospital",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":138,"conditions":139,"keywords":147,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100609357","enhanced-valves-interventions-and-safe-ai-generated-end-results-100609357","NCT07213531","Enhanced Valves Interventions and Safe AI Generated End Results","ENVISAGE","Inclusion Criteria:\n\nPatients who have reached the age of legal majority under local laws.\n\n* For TAVI group: All patients who have had TAVI with a third generation transcatheter heart valve (THV), with an available pre-procedural optimal quality CT scan as defined by an ECG- gating CT with:\n\n  1. five to ten image volumes at cardiac phases from 5% to 95% R-R\n  2. 0.625 mm slice thickness\n  3. 0.625 mm spacing between slices\n  4. 0.88 mm in-plane pixel spacing\n* For TMVI group: Patients who have had a TMVI with a dedicated device and screen failures, with an available optimal quality CT scan.\n* For TTVI group: Patients who have had a TTVI with a dedicated device and screen failures, with an available optimal quality CT scan.\n* For M-TEER: All patient who have had a M-TEER with 1) G4 or newer iteration of MitraClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos images from one of two vendors: Phillips or GE, with clear identifiable views of the Mitral valve, frame per second equal or higher than 40 frames per second, acceptable 3D reconstructions.\n* For T-TEER: All patient who have had a T-TEER with G4 or newer iteration of TriClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos images from one of two vendors: Phillips or GE, with clear identifiable views of the Tricuspid valve, frame per second equal or higher than 40 frames per second, acceptable transgastric image with acceptable 3D reconstructions.\n\nExclusion Criteria:\n\n* For TAVI group: Valve-in-valve procedures\n* For TMVI group: Valve-in-valve and valve-in-ring procedures\n* For TTVI: Valve-in-valve and valve-in-ring procedures\n* For M-TEER: G3 or older MitraClip, G1 Pascal\n* For T-TEER: G3 Triclip, G1 Pascal",{"count":137,"type":21},21000,"This non-interventional study aims to use artificial intelligence to improve the prediction of transcatheter heart valve interventions and optimize patient outcomes. It is based on the analysis of retrospective data from various specialized centers worldwide.",[140,28,141,142,143,144,145,146],"Heart Valve Disease","M-TEER","TTVI","TMVI","T-TEER","Mitraclip","TriClip",[148,149,150,141,144,28,143,151,152],"Medical imaging","CT","Artificial intelligence","valvulopathy","predictive algorithms","2025-10-01",{"date":155,"type":39},"2025-10-09",{"date":157,"type":39},"2024-05-01",{"date":159,"type":21},"2029-05",{"name":161,"class":104},"Montreal Heart Institute",15,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":171,"targetDuration":173,"studyType":114,"phases":4,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":47},"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":172,"type":21},100,"3 Months","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.",[29,28,176,177],"Quality of Life","Mental Health",[179,180,181,182,183,184,185],"Transcatheter aortic valve implantation (TAVI)","quality of life","Kansas City Cardiomyopathy Questionnaire","Mini-Montreal Cognitive Assessment (Mini-MoCA)","life expectancy","Mental health","Clinical Frailty Scale (CFS)","2025-09-24",{"date":188,"type":39},"2025-09-30",{"date":190,"type":21},"2025-11-01",{"date":192,"type":21},"2027-02-01",{"name":194,"class":104},"University Hospital Plymouth NHS Trust",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"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":203,"type":21},400,[60],"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.",[207,66,28],"Aortic Valve Disease",[74,28,209,210],"Rapid atrial pacing","Aortic stenosis","2024-12-09",{"date":213,"type":39},"2024-12-12",{"date":215,"type":39},"2024-03-01",{"date":217,"type":21},"2025-12-31",{"name":219,"class":104},"National and Kapodistrian University of Athens",2,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":227,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":47},"100426357","hypothyroidism-after-the-tavi-procedure-in-elderly-patients-100426357","NCT04831957","Hypothyroidism After the TAVI Procedure in Elderly Patients","Inclusion Criteria:\n\n* Provision of signed and dated, written Informed Consent prior to any study specific proce-dures\n* Patient: males and females must be ≥ 70 years old\n* Patients who will undergo a TAVI procedure\n\nExclusion Criteria:\n\n* \\- No obtained signed, dated and written Informed Consent.\n* Known thyroid dysfunction (for example: Basedow, Hashimoto,...)\n* Patients receiving any of the following: Lithium, Strumazol or a recent treatment of radio-Iode","70 Years",{"count":229,"type":21},20,[60],"Aortic stenosis is highly prevalent in advancing age. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve and the trans catheter aortic valve re-placement (TAVI). The TAVI procedure is also successful in octogenarians and frail patients. However, the evaluation before the TAVI procedure requires a high dosage of iodinated contrast agent with, consequently, an increased risk for thyroid dysfunction. The primary endpoint of this study is to assess, prospectively, the incidence and the predictive factors (underlying thyroid disease, medication, food preservative, topical antiseptics) of hypothyroidism after a TAVI procedure. The secondary endpoint is the influence of the occurrence of hypothyroidism after the TAVI procedure on the geriatric assessment.",[233,28],"Hypothyroidism",[233,28],"2024-12-04",{"date":211,"type":39},{"date":238,"type":39},"2021-07-26",{"date":240,"type":21},"2050-12-31",{"name":242,"class":104},"Universitair Ziekenhuis Brussel",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":250,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":47},"100486678","virtual-prehab-study-for-patients-undergoing-tavi-100486678","NCT05617196","Virtual PREHAB Study for Patients Undergoing TAVI","Feasibility of a Virtually Delivered Preoperative Rehabilitation Program for Patients Awaiting TAVI to Reduce Frailty: The Virtual PREHAB Study","Inclusion Criteria:\n\n* Outpatients attending the TAVI clinic at the Queen Elizabeth II Health Sciences Centre\n* Informed written or verbal consent\n\nExclusion Criteria:\n\n* New York Heart Association or Canadian Cardiovascular Score of 4\n* Severe functional limitations\n* Cognitive impairment that impacts consenting ability\n* Significant language barrier\n* No internet or telephone access that precludes virtual PREHAB participation","50 Years","100 Years",{"count":113,"type":21},[60],"Nova Scotians are aging and many are becoming frailer. People with frailty are more likely to live in worse health and do not recover well from major events, such as open heart surgery. Many people are also too frail to receive open heart surgery. Less invasive procedures called transcatheter aortic valve implantation, or TAVI, are provided for the frailest patients. While TAVI is life-saving, frailer patients are less likely to survive in better health after their operation. Patients in Nova Scotia can also wait up to 3-6 months for their operation where they become frailer or can die before receiving TAVI. The investigators believe that it is important to support these individuals to improve their frailty and overall health before their operation.\n\nCenter-based cardiac rehabilitation is offered to patients after, but not before TAVI to improve their health. Center-based preoperative cardiac rehabilitation (i.e., PREHAB) can safely improve the function of frail patients who received open heart surgery. However, many patients cannot come to a center-based PREHAB because of transportation requirements to access the program. Another option is to support these patients with virtually delivered PREHAB, where they can stay in their homes. However, this possibility has not been studied.\n\nFor this study, virtual PREHAB will be delivered using the virtual cardiac rehabilitation program in Nova Scotia to patients before TAVI. This intervention will be delivered by healthcare providers who routinely care for TAVI patients, including a medical director, program lead, nurse, physiotherapist, and dietician. Ther goal of this study is to determine if it is feasible and safe to use virtual PREHAB to reduce frailty before TAVI. This research fits with Research Nova Scotia's priorities to improve patient outcomes in those with significant long-term health conditions, and to provide accessible, safe, and quality virtual healthcare to patients so they can thrive after their operation.",[256,257,28],"Cardiovascular Diseases in Old Age","Frailty",[257,259,260,28],"Virtual PREHAB","Cardiac rehabilitation","2024-08-19",{"date":263,"type":39},"2024-08-21",{"date":265,"type":39},"2023-01-05",{"date":267,"type":21},"2025-12",{"name":269,"class":104},"Nova Scotia Health Authority",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":277,"maxAge":251,"enrollmentInfo":278,"targetDuration":280,"studyType":114,"phases":4,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":47},"100457358","effectavi-registry-100457358","NCT05235555","EffecTAVI Registry","Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry","Inclusion Criteria:\n\n1. Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation;\n2. Ability to provide informed consent.\n\nExclusion Criteria:\n\n1. Contraindications to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis;\n2. Poor adherence to scheduled follow-up;\n3. Unable to understand and follow study-related instructions.","55 Years",{"count":279,"type":21},1000,"10 Years","Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears.\n\nFor several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI. Furthermore, newer generations of transcatheter heart valve (THV) design, better patient selection, and technical enhancements have driven improvement in safety and reduction of procedural complications over time.\n\nThis observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.",[27,283,28],"Transcatheter Aortic Valve Replacement",[27,283,28],"2024-02-22",{"date":287,"type":39},"2024-02-23",{"date":289,"type":39},"2015-09-01",{"date":291,"type":21},"2030-01-01",{"name":293,"class":104},"Federico II University"]