Functional outcomes after TAVI II (FASTER-II)
Research type
Research Study
Full title
Functional outcomes in Aortic Stenosis after TranscathetER valve implantation II (FASTER-II)
IRAS ID
253035
Contact name
Simon Redwood
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Aortic stenosis (AS), is a condition in which the aortic valve becomes narrowed as people get older, causing the heart pump (the left ventricle) to struggle to push blood through it, leading to breathlessness, chest pain and blackouts. If left untreated, the prognosis is bleak (similar to lung cancer). Previously the only effective treatment for AS was a valve replacement via open heart surgery, which was too high risk for many patients to undergo, meaning they were left without treatment. In transcatheter aortic valve implantation (TAVI) a new valve is inserted through a small tube, usually in the leg artery, which avoids open heart surgery; revolutionising the treatment of AS for patients who are high or too high risk for open heart surgery.
Rates of TAVI procedural success are very high (over 95%). However, a significant minority of patients undergoing TAVI derive little or no benefit from the procedure. Nearly a third describe no improvement in quality of life, or die within the first year. To combat this problem, it is essential we develop more sophisticated means of selecting patients in whom the procedure is appropriate, to avoid futile interventions from which they will not benefit. Current tools available for this are inadequate. As part of an ongoing study (FASTER, IRAS 253035) we are investigating the feasibility of an easy to use accelerometer (Fitbit, San Francisco, CA) to provide objective, continuous measurement of activity in patients undergoing TAVI. We have hypothesised that the activity monitor will provide objective, high fidelity, home-environment acquired data, which will offer a unique insight into functional improvement over and above existing measures.
The purpose of this related study, is to include of a cohort of participants to undergo more detailed investigation to characterise the change in functional activity measured by the accelerometer in the context of the anatomical and physiological adaptions that occur after TAVI, considerably strengthening our scientific understanding of the activity monitoring observations.
The results from the study will ultimately aim to inform the future development of novel risk assessment and patient selection tools for TAVI.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1978
Date of REC Opinion
11 Jan 2019
REC opinion
Further Information Favourable Opinion