Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT07193004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life Improvement After TAVI (QualiTAVI-UK Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of QoL', 'timeFrame': '30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI', 'description': 'This is defined as improvement in QoL scores from baseline to 3 months post-TAVI. Based on KCCQ-12, a change of 5 points (small but clinically important change), 10 points (moderate-to-large), and 20 points (large-to-very large clinical changes). Based on CFS score, worsened frailty is defined as an increase in CFS score of +4, and improved frailty by a decrease of -2.'}], 'secondaryOutcomes': [{'measure': 'Correlation between life expectancy and QoL improvements', 'timeFrame': '30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI', 'description': 'Correlation between life expectancy and QoL improvements using regression analysis. Mental health and cognitive function (Mini-MoCA scores), frailty status (CFS), will be explored as potential mediators of QoL outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['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)'], 'conditions': ['TAVI(Transcatheter Aortic Valve Implantation)', 'TAVI', 'Quality of Life', 'Mental Health']}, 'referencesModule': {'references': [{'pmid': '35275374', 'type': 'BACKGROUND', 'citation': 'Monnin C, Besutti M, Ecarnot F, Guillon B, Chatot M, Chopard R, Yahia M, Meneveau N, Schiele F. Prevalence and severity of cognitive dysfunction in patients referred for transcatheter aortic valve implantation (TAVI): clinical and cognitive impact at 1 year. Aging Clin Exp Res. 2022 Aug;34(8):1873-1883. doi: 10.1007/s40520-022-02102-2. Epub 2022 Mar 11.'}, {'pmid': '28302751', 'type': 'BACKGROUND', 'citation': 'Shimura T, Yamamoto M, Kano S, Kagase A, Kodama A, Koyama Y, Tsuchikane E, Suzuki T, Otsuka T, Kohsaka S, Tada N, Yamanaka F, Naganuma T, Araki M, Shirai S, Watanabe Y, Hayashida K; OCEAN-TAVI Investigators. Impact of the Clinical Frailty Scale on Outcomes After Transcatheter Aortic Valve Replacement. Circulation. 2017 May 23;135(21):2013-2024. doi: 10.1161/CIRCULATIONAHA.116.025630. Epub 2017 Mar 16.'}, {'pmid': '34810276', 'type': 'BACKGROUND', 'citation': 'Kennon S, Styra R, Bonaros N, Stastny L, Romano M, Lefevre T, Di Mario C, Stefano P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Luske C, Bramlage P, Frank D. Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire. Open Heart. 2021 Nov;8(2):e001821. doi: 10.1136/openhrt-2021-001821.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Study Title uality of Life Improvement after Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK trial)\n\nStudy Design This is a prospective, single-center study that will be conducted over 1 year at Derriford Hospital, University Hospitals Plymouth, UK.\n\nStudy Participants The study will include all patients undergoing TAVI for severe AS during this period.\n\nEligibility Criteria Inclusion Criteria: 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: Patients who declined enrollment in this research.\n\nPlanned Sample Size More than 100 patients\n\nFollow-up Duration 3 months\n\nPlanned Study Period 1 year\n\nPrimary Objective This study aims to address the knowledge gap regarding the impact of TAVI on Quality of Life (QoL) Secondary Objective -"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': "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."}, 'identificationModule': {'nctId': 'NCT07193004', 'acronym': 'QualiTAVI-UK', 'briefTitle': 'Quality of Life Improvement After TAVI (QualiTAVI-UK Trial)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Plymouth NHS Trust'}, 'officialTitle': 'Quality of Life Improvement After Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK Trial)', 'orgStudyIdInfo': {'id': '25/CAR/222'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAVI', 'description': "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.", 'interventionNames': ['Behavioral: Quality of Life']}], 'interventions': [{'name': 'Quality of Life', 'type': 'BEHAVIORAL', 'otherNames': ['KCCQ-12', 'CFS', 'Mini-MoCA'], 'description': '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.', 'armGroupLabels': ['TAVI']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'centralContacts': [{'name': 'Ayman Helal, MD Cardiology', 'role': 'CONTACT', 'email': 'ayman.helal1@nhs.net', 'phone': '+447376863806'}, {'name': 'Venkatesan Suresh, MD Cardiology', 'role': 'CONTACT', 'email': 'vsuresh@nhs.net', 'phone': '+447766460037'}], 'overallOfficials': [{'name': 'Ayman Helal, MD Cardiology', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospitals Plymouth NHS Trust'}, {'name': 'Ayman Helal, MD Cardiology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Plymouth NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Relevant information related to the study will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Plymouth NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ayman Helal', 'investigatorAffiliation': 'University Hospital Plymouth NHS Trust'}}}}