Cost outcomes study of transcatheter aortic valve implantation with contemporary valves
| ISRCTN | ISRCTN14725744 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14725744 |
| Integrated Research Application System (IRAS) | 363673 |
| Central Portfolio Management System (CPMS) | 71884 |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Funder | Meril Life Sciences |
- Submission date
- 22/05/2026
- Registration date
- 24/06/2026
- Last edited
- 24/06/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The transcatheter aortic valve implantation (TAVI) procedure has been in clinical practice for several years for patients who suffer from significant symptoms due to a narrowed aortic valve and who cannot undergo an open-heart operation due to various reasons, for example, if they are elderly and are at high risk of complications after major operations. In these patients, the TAVI procedure is a good alternative and has shown to improve quality of life and prognosis. There are several TAVI valves available; however, only three of them have been tested in randomised clinical trials. There is a continuous and significant increase in the number of patients undergoing TAVI procedures every year. As these valves are expensive, this has resulted in a significant burden on the NHS budget in treating these patients. The purpose of this study is to assess if, following implantation, there is any difference between the three contemporary aortic transcatheter heart valves (THVs), i.e., the Meril Myval THV Series, the Edwards Sapien THV Series and the Medtronic Evolut THV Series, in health-related quality of life and cost-effectiveness of the TAVI procedure. This trial will provide valuable data which can be used to develop future guidance about how to manage these patients with aortic valve narrowing in a cost-effective manner.
Who can participate?
Patients aged 18 years and over who have been scheduled to undergo TAVI as part of normal clinical care.
What does the study involve?
Once a participant has agreed to participate and signed the consent form, the research team will collect existing information that their clinical care team have recorded about their physical health, medications and tests, including an ultrasound scan of the heart and a CT scan. The research team will complete a quality-of-life assessment with the patient using some questionnaires, which takes around 15 minutes.
They will be randomly allocated to have TAVI with one of the three valves (Evolut, Sapien or Myval THV series), which are all currently being used in routine clinical practice in the NHS. All these valves are backed by robust clinical effectiveness data in large trials. A computer will select the valve they receive at random.
The TAVI procedure will be done by the clinical team as per standard clinical care. The research team will collect the procedural information.
Around 30 to 45 days after the TAVI procedure, the research team will complete the same quality-of-life assessment again, either during a face-to-face clinic appointment or over the telephone. The results of this will be compared with the assessment before the TAVI procedure. If the participant attends a face-to-face clinic appointment for this assessment, your travel expenses will be provided by the research team. This visit would be in addition to any follow up that the local healthcare team may decide to do as part of their routine clinical care post-TAVI.
The local care team would write to the participant's GP (with permission) to inform them that they are taking part in this study.
What are the possible benefits and risks of participating?
Although there are no direct benefits for taking part in this study (as we are only collecting information from the planned procedure). It is hoped that this research will benefit future patients and health services.
Nevertheless, participants will have an additional review at 30 (+15) days, either in person or via telephone (as per preference); participants will be asked to complete a questionnaire to assess quality of life and compare it with the assessment before the TAVI procedure. The research team can then inform the clinical care team if any adverse event is identified.
Where is the study run from?
Northern General Hospital (UK)
When is the study starting and how long is it expected to run for? 1 year and 6 months.
May 2026 to November 2027
Who is funding the study?
Meril Lifesciences Pvt. Ltd (India)
Who is the main contact?
Dr Javaid Iqbal, javaid.iqbal3@nhs.net
Contact information
Public
Academic Directorate of Cardiology and Cardiothoracic Surgery
NGH, Centre for Biomedical Research
B Floor
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)7584202046 |
|---|---|
| amber.ford3@nhs.net |
Scientific
STH NGH
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)114 243 4343 |
|---|---|
| javaid.iqbal3@nhs.net |
Principal investigator
STH NGH
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)114 243 4343 |
|---|---|
| m.aetesam-ur-rahman@nhs.net |
Scientific
Northern General Hospital
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)114 243 4343 |
|---|---|
| Muhammad.khan280@nhs.net |
Scientific
Academic Directorate of Cardiology and Cardiothoracic Surgery
NGH, Centre for Biomedical Research
B Floor
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)7584187702 |
|---|---|
| h.denney@nhs.net |
Scientific
CRIO, Royal Hallamshire Hospital, Glossop Road
Sheffield
S10 2JF
United Kingdom
| Phone | +44 (0)114 226 5932 |
|---|---|
| Samantha.walsmley@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Cost Outcomes Study of Transcatheter Aortic Valve Implantation with contemporary valves: the COS-TAVI Trial |
| Study acronym | COS-TAVI |
| Study objectives | The primary objective is to compare the cost effectiveness of three main TAVI devices used in contemporary practice. The principal question that will be addressed by this trial is whether there is any difference in health-related quality of life and cost-effectiveness by implantation of one of the three TAVI devices. |
| Ethics approval(s) |
Approved 29/04/2026, North East - Newcastle & North Tyneside 2 Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 26/NE/0075 |
| Health condition(s) or problem(s) studied | 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 |
| Intervention | 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. Patients who meet the inclusion and exclusion criteria and are willing to participate after reading the patient information sheet will be enrolled in this trial. Patients will sign the study consent form. The research team will then collect baseline demographic and clinical data, including routine tests performed as work-up for TAVI. Participants will have their baseline quality of life assessment as part of the trial. Participants would then be randomised to one of three study arms – the Myval THV series, the Sapien THV series or the Evolut THV series – and undergo the TAVI procedure as per the clinical guidelines and local study centre protocols. Participants will have standard post-TAVI care as per local guidelines and be discharged when the clinical team makes that decision. The research team will collect the details of the procedure, any adverse events/serious adverse events and the costs of the procedure and care. The research team will review participants either face-to-face or in a telephone call at 30 (+15) days post-TAVI to assess quality of life and any adverse/serious adverse events. Participants would also be enquired about the number of times they had to approach health and social care services (e.g., GP visits, hospital admissions, care home or nursing home stays), and they would be costed as per the national average tariff for each visit/use. This would be the end of the study, but patients will continue to have their clinical care and follow-up as per the local protocol of the study centre. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Health-related quality of life measured using EQ-5D-5L Questionnaire at 30(+15) days |
| Key secondary outcome measure(s) |
Health economics: |
| Completion date | 10/11/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 666 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 11/05/2026 |
| Date of final enrolment | 30/03/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Herries Road
Sheffield
S5 7AU
England
Infirmary Square
Leicester
LE1 5WW
England
Anlaby Road
Hull
HU3 2JZ
England
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
Liverpool
L14 3PE
England
Clifford Bridge Road
Coventry
CV2 2DX
England
Cambridge Biomedical Campus
Cambridge
CB2 0AY
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
22/05/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
