Condition category
Circulatory System
Date applied
12/06/2013
Date assigned
12/06/2013
Last edited
04/04/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
The study started in August 2013 and will run until July 2016.

Who is funding the study?
NIHR Health Technology Assessment (UK).

Who is the main contact?
Dr William D. Toff
w.toff@le.ac.uk

Trial website

http://www.uktavi.org

Contact information

Type

Scientific

Primary contact

Dr William D Toff

ORCID ID

Contact details

Department of Cardiovascular Sciences
University of Leicester
Clinical Sciences Wing
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
w.toff@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14550

Study information

Scientific title

Acronym

UK TAVI

Study hypothesis

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

First Medical Research Ethics Committee (MREC), 10/04/2013, 13/LO/0451

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiac Surgery

Intervention

Surgical AVR, Surgical Aortic Valve Implantation; TAVI, Transcatheter Aortic Valve Implantation; Follow Up Length: 60 month(s); Study Entry: Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2013

Overall trial end date

31/07/2016

Reason abandoned

Eligibility

Participant 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 investigator’s opinion) and willing to comply with all study requirements
Target gender: Male and female; lower age limit: 70 years

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 808; UK Sample Size: 808

Participant 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

Recruitment start date

01/08/2013

Recruitment end date

31/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiovascular Sciences
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University of Leicester (UK)

Sponsor details

Research Governance Office
University of Leicester
Academic Department
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor type

University/education

Website

http://www.le.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment; Grant Codes: 09/55/63

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes