UnknownNot Applicable

INTERvention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi)

United Kingdom120 participantsStarted 2021-09-01

Plain-language summary

The study aims to evaluate the processes of a pilot single-centre randomised controlled trial (RCT) of carbon-dioxide flushing of transcatheter aortic valves (TAVI-CO2) versus standard saline flushing of valves (TAVI-S) and assess potential neuroprotection through a number of neurological endpoints for planning of a full-sized RCT

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients between the ages of 18 and 100 years undergoing transcatheter aortic valve implantation (TAVI) for aortic stenosis under local anaesthetic. Exclusion Criteria: * Patients that lack capacity to provide informed consent * Patients that have had a stroke within 12 months * Patients aged less than 18 years of age * Patients that are pregnant

What they're measuring

Number of participants suitable for recruitment for larger RCT

Timeframe: Duration of study, approximately 15 months

Trial details

NCT IDNCT05146037

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Saud Ahmed Khawaja, MBBS

+44 203 313 1626 Saud.khawaja@nhs.net

View on ClinicalTrials.gov More Stroke trials