Topic: Cardiovascular
Conditions
Interventions
1. Surgical AVR, Surgical Aortic Valve Implantation
2. TAVI, Transcatheter Aortic Valve Implantation
Follow Up Length: 60 month(s)
Sponsors
University of Leicester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality; Timepoint(s): One year | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ext | — |
Countries
England, United Kingdom
Outcome results
None listed