The United Kingdom Transcatheter Aortic Valve Implantation (UK TAVI) Trial. A multi-centre randomised controlled trial to assess the clinical effectiveness and cost utility of TAVI, compared with conventional surgical aortic valve replacement (AVR), in patients with severe symptomatic aortic stenosis at intermediate or high operative risk
| ISRCTN | ISRCTN57819173 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57819173 |
| Secondary identifying numbers | 14550; HTA 09/55/63 |
- Submission date
- 12/06/2013
- Registration date
- 12/06/2013
- Last edited
- 18/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Aortic stenosis is a narrowing of the valve through which blood flows as it leaves the heart, and affects 13% of people over the age of 70 years. It is usually due to age-related degeneration. If the narrowing becomes severe, chest pain, breathlessness, fluid retention and fainting are common, and the outlook is poor with a high risk of death within 2-3 years. The only effective conventional treatment is surgical replacement of the valve, which involves open chest surgery and temporarily stopping the heart, with use of a heart-lung machine. Surgical results are generally excellent but the elderly often have other medical problems that may result in an increased risk of death and complications. Transcatheter Aortic Valve Implantation (TAVI) is a recently developed technique to implant an artificial aortic valve without major surgery, using a catheter to deliver the valve to the heart through the arteries, which are usually accessed by puncturing the skin in the groin. In some cases, the valve is delivered directly through a small incision in the chest wall. The proposed study will compare TAVI with conventional surgery.
Who can participate?
Patients aged 70 years or over for whom either treatment is an option but in whom the risks of surgery are considered by an expert local medical team to be intermediate or high.
What does the study involve?
Each patient who consents to take part will be randomly assigned to receive either TAVI or surgery. Outcomes in each group will be compared to see whether TAVI offers advantages in the short term and whether the long-term results, over 5 years, are as good as surgery. The cost implications for the NHS will be assessed to see if TAVI offers value for money.
What are the possible benefits and risks of participating?
The results of the study will inform NHS policy for the use of TAVI and guide treatment decisions for future patients.
Where is the study run from?
University of Leicester (UK)
When is the study starting and how long is it expected to run for?
August 2013 to October 2022
Who is funding the study?
NIHR Health Technology Assessment (UK)
Who is the main contact?
Dr William D. Toff
w.toff@le.ac.uk
Contact information
Scientific
Department of Cardiovascular Sciences
University of Leicester
Clinical Sciences Wing
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| w.toff@le.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The United Kingdom Transcatheter Aortic Valve Implantation (UK TAVI) Trial. A multi-centre randomised controlled trial to assess the clinical effectiveness and cost utility of TAVI, compared with conventional surgical aortic valve replacement (AVR), in patients with severe symptomatic aortic stenosis at intermediate or high operative risk |
| Study acronym | UK TAVI |
| Study objectives | Aortic stenosis, narrowing of the valve through which blood flows as it leaves the heart, affects 1-3% of people over the age of 70 years. It is usually due to age-related degeneration. If the narrowing becomes severe, chest pain, breathlessness, fluid retention and fainting are common, and the outlook is poor with a high risk of death within 2-3 years. The only effective conventional treatment is surgical replacement of the valve, which involves open chest surgery and temporarily stopping the heart, with use of a heart-lung machine. Surgical results are generally excellent but the elderly often have other medical problems that may result in an increased risk of death and complications. Transcatheter Aortic Valve Implantation (TAVI) is a recently developed technique to implant an artificial aortic valve without major surgery, using a catheter to deliver the valve to the heart through the arteries, which are usually accessed by puncturing the skin in the groin. In some cases, the valve is delivered directly through a small incision in the chest wall. The proposed study will compare TAVI with conventional surgery in a group of patients, aged 70 years or over, for whom either treatment is an option but in whom the risks of surgery are considered by an expert local medical team to be intermediate or high. Each patient who consents to take part will be randomly assigned to receive either TAVI or surgery. Outcomes in each group will be compared to see whether TAVI offers advantages in the short-term and whether the long-term results, over 5 years, are as good as surgery. The cost implications for the NHS will be assessed to see if TAVI offers value for money. The results of the study will inform NHS policy for the use of TAVI and guide treatment decisions for individual patients. The primary study hypothesis is that in patients with severe symptomatic aortic stenosis who are at intermediate or high operative risk, Transcatheter Aortic Valve Implantation (TAVI) is non-inferior to surgical aortic valve replacement in respect of death from any cause at one year. |
| Ethics approval(s) | First Medical Research Ethics Committee (MREC), 10/04/2013, 13/LO/0451 |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiac Surgery |
| Intervention | 1. Surgical AVR, Surgical Aortic Valve Implantation 2. TAVI, Transcatheter Aortic Valve Implantation Follow Up Length: 60 month(s); Study Entry: Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | All-cause mortality; Timepoint(s): One year |
| Secondary outcome measures | 1. All-cause mortality at 30 days, 2, 3, 4 and 5 years 2. Cardiovascular mortality at 30 days and annually to 5 years 3. Quality-adjusted survival at 3 months and annually to 5 years 4. Stroke at 30 days and annually to 5 years 5. Re-intervention at 30 days and annually to 5 years 6. Death from any cause or stroke at 30 days and annually to 5 years 7. Death from any cause or disabling stroke at 30 days and annually to 5 years 8. Death from any cause, stroke or re-intervention at 30 days and annually to 5 years 9. Quality of life (Minnesota Living With Heart Failure Questionnaire at 6 weeks and 1 year; EQ-5D-5L at 2 weeks, 6 weeks, 3 months, 6 months and annually to 5 years) 10. Symptoms and functional capacity (CCS scale and NYHA class at 6 weeks, 3 months, 6 months and annually to 5 years; Nottingham EADL and 6-min walk at 6 weeks and 1 year) 11. Cognitive function (Mini-Mental-State-Index at 6 weeks and 1 year) 12. Procedural success and in-hospital complications 13. Duration of post-procedural hospital stay 14. Vascular complications at 30 days and 1 year 15. Major bleeding at 30 days and 1 year 16. Infective endocarditis at 30 days and annually to 5 years 17. Myocardial infarction at 30 days and annually to 5 years 18. Conduction disturbance requiring permanent cardiac pacing pre-discharge and at 1 year 19. Renal replacement therapy at 30 days and 1 year 20. Echocardiographic measures (left ventricular ejection fraction, mass, dimensions and volumes; aortic regurgitation; aortic valve gradient and area, at 6 weeks and 1 year) 21. Costs, cost-utility and incremental cost-effectiveness ratio at 1 year, 5 years and estimated over lifetime using an extrapolation model |
| Overall study start date | 01/08/2013 |
| Completion date | 31/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 808; UK Sample Size: 808 |
| Total final enrolment | 913 |
| Key inclusion criteria | 1. Severe symptomatic aortic stenosis referred for intervention 2. Age ≥80 years or age ≥70 years with intermediate or high operative risk from conventional AVR, as determined by the MDT 3. Both conventional AVR and TAVI deemed to be acceptable treatment options; 4. Participant able and willing to give written informed consent 5. Participant able (in the investigators opinion) and willing to comply with all study requirements Target gender: male and female; lower age limit: 70 years |
| Key exclusion criteria | 1. Intervention deemed inappropriate due to co-morbidity or frailty 2. Life expectancy less than one year due to co-morbidity 3. Previous AVR or TAVI 4. Technically unsuitable for either AVR or TAVI 5. Concomitant coronary artery disease requiring revascularisation for which only surgery is considered appropriate 6. Predominant aortic regurgitation 7. Severe mitral regurgitation or likely need for concomitant surgery or cardiac intervention other than planned coronary artery surgery or percutaneous coronary intervention as part of the treatment strategy |
| Date of first enrolment | 01/08/2013 |
| Date of final enrolment | 31/03/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
LE3 9QP
United Kingdom
Sponsor information
University/education
Research Governance Office
University of Leicester
Academic Department
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Website | http://www.le.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/05/2022 | 18/05/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
18/05/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
29/11/2017: The recruitment end date was changed from 31/10/2017 to 31/03/2018.
10/04/2017: The overall trial end date was changed from 31/07/2016 to 31/10/2022.
