Transcatheter aortic valve implantation (TAVI) procedure for patients who suffer from significant symptoms due to a narrowed aortic valve and who cannot undergo an open-heart operation Circulatory System
Conditions
Interventions
All patients with severe symptomatic narrowing of the aortic valve, where the local clinical team decides to offer the TAVI procedure to them, will be screened to assess suitability for the trial. Pat
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2. Informed consent to participate in the trial 3. Patients with severe aortic stenosis are eligible for TAVI with all the study devices as per the local heart team 4. TAVI planned via percutaneous transfemoral access
Exclusion criteria
Exclusion criteria: 1. Any participant who, in expert opinion of the local heart team, is not suitable for at least one of the study devices due to either technical limitations, high/unacceptable risk of complications if the device is implanted in that participant or reported hypersensitivity or allergy to any of the elements of the study device. 2. Participation in another clinical trial using TAVI devices not approved for routine clinical use 3. Participation in another trial which may affect cost outcomes 4. Patients undergoing any planned concomitant procedures, for example, percutaneous coronary intervention (PCI) or peripheral arterial stenting at the time of TAVI 5. Patient needing another planned surgery or procedure (for example, to treat a cancer) within 6 weeks of TAVI 6. The following patient groups will be excluded as they represent a small proportion of patients undergoing transfemoral TAVI in the UK and are associated with substantially different procedural pathways and clinical risk profiles, which may introduce significant heterogeneity in short-term clinical outcomes and resource utilisation. Exclusion of these groups is intended to ensure comparability between treatment arms and preserve the internal validity of the cost-effectiveness analysis. 6.1. TAVI procedure planned under general anaesthesia (GA) 6.2. Patients with advanced kidney disease (CKD stage 4 or 5 or patients on haemodialysis) 6.3. Severely impaired left ventricular systolic function with ejection fraction (EF) less than 30% 6.4. Patient admitted to hospital for inpatient TAVI 6.5. TAVI in failed surgical aortic valve prosthesis with high risk of coronary obstruction requiring leaflet modification or coronary protection (VIVID class IIB, IIIB and IIIC) 6.6. Redo TAVI in failed TAVI prosthesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life measured using EQ-5D-5L Questionnaire at 30(+15) days 2. Total cost incurred in patient treatment from the time of procedure until 30 days post-procedure, measured using cost collected from hospital finance department for procedure, investigation and hospitalisation costs, and national average cost for primary and social care resource use | — |
Secondary
| Measure | Time frame |
|---|---|
| Health economics: 1. Relative cost-effectiveness of the different TAVI valves over the estimated lifetime of treated patients, measured using cost of hospitalisation and primary and social care national average cost and then estimated over patient lifetime based on Office for National Statistics (ONS) data of the life expectancy of such participants 2. Quality-adjusted life years (QALYs) measured using EQ-5D-5L questionnaire country-specific index at 30 days and modelled over patients’ lifetime 3. Incremental net monetary benefit (INMB) and incremental cost-effectiveness ratio (ICER) at 30 days, measured using mathematical/health economic calculations directly linked to quality of life and costs 4. Incremental cost per QALY at 30 days for each valve measured using mathematical calculation: cost of every device/QALY improvement with that device 5. Procedural efficiency (procedural time, contrast dose, radiation dose) measured using hospital paper or electronic records and direct input in electronic data capture (EDC) and electronic case report form (eCRF) by research staff at index procedure 6. Length of index hospital stay post-TAVI procedure, measured using hospital paper or electronic records 7. Rehospitalisation and number of days spent in hospital by 30 days, measured using hospital paper or electronic records 8. Resource use and costs to the NHS and social services at 30 days and modelled over the lifetime of patients, measured using direct costs calculation from hospital finance department and national average costs for primary care and social care resources over 30-day follow-up and then modelled based on the life expectancy of such patients Clinical and echocardiographic: 1. Mortality (procedural, in-hospital, 30 days) measured using direct entry by research team in EDC using hospital paper or electronic record or ONS 2. Stroke (procedural, in-hospital, 30 days) measured using direct entry by research team in EDC using hospital paper or electronic record 3. | — |
Countries
England, United Kingdom
Contacts
Public ContactAmber Ford
Outcome results
None listed