[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607780":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":30,"locations":39,"responsibleParty":52,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":10,"maxAge":10,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":81,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University Hospital Plymouth NHS Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TAVI",null,"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.",[13],"Behavioral: Quality of Life",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Quality of Life","Measures - We will use the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) to assess QoL, Mini-Montreal Cognitive Assessment (Mini-MoCA) to assess cognitive function, the Clinical Frailty Scale (CFS) to assess frailty status, and life expectancy estimation by the heart team to categorize patients as having: 1-2 years expected survival or more than 2 years expected survival (This will allow for an analysis of how life expectancy correlates with QoL improvements after TAVI).\n\nAssessment Timeline - Patients will be assessed at four key time points: at time of referral (baseline assessment), pre-procedure (to assess impact of delay on the patient), 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI (longer-term follow-up to evaluate sustained QoL changes). At each time point, the KCCQ-12, Mini-MoCA, and Clinical Frailty Scale (CFS) will be administered.",[9],[21,22,23],"KCCQ-12","CFS","Mini-MoCA",[25,28],{"name":26,"affiliation":5,"role":27},"Ayman Helal, MD Cardiology","STUDY_CHAIR",{"name":26,"affiliation":5,"role":29},"PRINCIPAL_INVESTIGATOR",[31,35],{"name":26,"role":32,"phone":33,"phoneExt":10,"email":34},"CONTACT","+447376863806","ayman.helal1@nhs.net",{"name":36,"role":32,"phone":37,"phoneExt":10,"email":38},"Venkatesan Suresh, MD Cardiology","+447766460037","vsuresh@nhs.net",[40],{"facility":41,"status":10,"city":42,"state":10,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":10},"Derriford Hospital","Plymouth","PL6 8DH","United Kingdom","UK",{"type":47,"coordinates":48},"Point",[49,50],-4.14305,50.37153,{"lat":50,"lon":49},{"type":29,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ayman Helal","Professor","100607780","quality-of-life-improvement-after-tavi-qualitavi-uk-trial-100607780",false,"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.","ALL",{"count":65,"type":66},100,"ESTIMATED","3 Months","OBSERVATIONAL","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.",[71,9,17,72],"TAVI(Transcatheter Aortic Valve Implantation)","Mental Health",[74,75,76,77,78,79,80],"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)","NOT_YET_RECRUITING","2025-09-24",{"date":84,"type":85},"2025-09-30","ACTUAL",{"date":87,"type":66},"2025-11-01",{"date":89,"type":66},"2027-02-01",{"name":5,"class":6},1]