Quality of Life Improvement After TAVI (QualiTAVI-UK Trial)

Официальное название

Quality of Life Improvement After Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK Trial)

Обзор

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.

Подробное описание

Study Title uality of Life Improvement after Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK trial)

Study Design This is a prospective, single-center study that will be conducted over 1 year at Derriford Hospital, University Hospitals Plymouth, UK.

Study Participants The study will include all patients undergoing TAVI for severe AS during this period.

Eligibility 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.

Exclusion Criteria: Patients who declined enrollment in this research.

Planned Sample Size More than 100 patients

Follow-up Duration 3 months

Planned Study Period 1 year

Primary Objective This study aims to address the knowledge gap regarding the impact of TAVI on Quality of Life (QoL) Secondary Objective -

Вмешательства

• Поведенческое 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). Assessment Timelin

Первичные конечные точки

• Improvement of QoL [Срок оценки: 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI]

Вторичные конечные точки (1)

• Correlation between life expectancy and QoL improvements [Срок оценки: 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Patients who declined enrollment in this research.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• Derriford Hospital — Plymouth

Публикации

• 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 35275374
• 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 PMID 28302751
• 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 Hea PMID 34810276
• Gonnah AR, Abdelwahab M, Taylor R, Labib A, Masoud O, Debski M, Abdelaziz HK, Roberts DH. Health-related quality of life following TAVI or cardiac surgery in patients at intermediate and low risk: a systematic review and meta-analysis. Clin Med (Lond). 2023 Nov;23(6):594-605. doi: 10.7861/clinmed.2023-0258. PMID 38065591

Идентификаторы

NCT: NCT07193004 · 25/CAR/222

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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