INTERvention with Cerebral Embolic Protection in TAVI: INTERCEPTavi
Research type
Research Study
Full title
INTERvention with Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi): ‘Carbon-Dioxide Flushing versus Saline Flushing of Transcatheter Aortic Valves: A Single-centre Randomised Controlled Trial’
IRAS ID
291833
Contact name
Ghada Mikhail
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Carbon-Dioxide Flushing versus Saline Flushing of Transcatheter Aortic Valves to Reduce Brain Injury and Stroke from Transcatheter Aortic Valve Implantation (TAVI): A Pilot Randomised Controlled Trial
The aortic valve is the main valve that controls blood to rest of your body. As patients get older, it can narrow due to wear and tear. Aortic stenosis is the commonest cause of valve disease in UK. Traditionally this was treated with cardiac surgery, requiring the chest bone to be opened and the heart to be stopped while the valve was replaced. This can be risky for older patients. Transcatheter Aortic Valve Replacement (TAVI) is a key hole procedure that can be done through the groin to replace the narrowed aortic valve with a new valve. This procedure can be done while patients are awake and they can go home the next day. While this procedure is being increasingly preferred over cardiac surgery, upto 5/100 patients risk having brain damage due to stroke and problems with their memory, affecting their everyday life activities. The brain injury is due to debris from the previous narrowed valve as well as air bubbles from the new valve. The air bubbles are normally removed by flushing the valve with salty water(saline). Flushing the valves with carbon dioxide may be a better way of removing any air and minimising brain damage.
Patients who undergo TAVI will be randomly allocated to undergo TAVI either with saline or CO2 flushing. They will have a brain scan, physical examination and memory tests before and after their procedure to look for any brain injury. They will also have non-invasive monitoring of blood flow to their brain during their procedure to look for air bubbles. The study aims to determine if CO2 flushing of TAVI valves is better at minimising brain damage.
REC name
Wales REC 7
REC reference
21/WA/0103
Date of REC Opinion
26 Mar 2021
REC opinion
Favourable Opinion