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

Not Applicable

• Conditions: Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiac Surgery; Circulatory System; Aortic (valve) stenosis

• Registration Number: ISRCTN57819173
• Lead Sponsor: niversity of Leicester (UK)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35579641/ (added 18/05/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-12
• Last Update Posted: 30 May 2022
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 913

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality; Timepoint(s): One year