BHF PROTECT TAVI is a 6-year research study, based in the UK which began in June 2020. The study aims to recruit 7730 participants who are undergoing Transcatheter Aortic Valve Implantation (TAVI) for aortic stenosis. The aim of the research is to understand whether the use of cerebral embolic protection devices during TAVI procedures impacts the risk of stroke. This will be evaluated using a randomised controlled trial study design.
All the study documentation for the trial can be found here.
About the study
Aortic stenosis (AS) is a common life-threatening condition, where blood flow out of the heart is restricted by narrowing of the aortic valve. There are two ways to treat AS. Transcatheter Aortic Valve Implantation (TAVI) inserts a new valve inside the existing diseased valve. Surgical aortic valve replacement (AVR) involves surgery on the heart to replace the diseased valve. TAVI is less invasive than surgical AVR. However, there are still risks with TAVI, including stroke and death. Stroke in TAVI can be caused by debris released into the bloodstream by the procedure. Devices, called cerebral embolic protection (CEP), have been developed that capture some of this debris using filters temporarily placed in the artery which provides blood to the brain. However, there is of yet no evidence that shows that CEP meaningfully reduces stroke in TAVI patients. This trial will address this evidence gap. In this study we will randomly assign patients receiving TAVI to receive CEP during TAVI or to the current standard of care without CEP. Potential participants will be approached prior to their TAVI procedure to discuss the trial. If they are happy to take part, full informed consent will be sought. Following the TAVI, we will assess whether participants have a stroke in the following 72 hours. We will also assess other ways the CEP treatment impacts on the NHS as well following-up participants for 12 months to assess their long-term outcomes. We will recruit 7730 participants across the UK over 6 years.
The target population for this trial is patients with severe aortic stenosis undergoing treatment by TAVI.
- Participant is willing and able to give informed consent for participation in the trial
- Participant is able to understand English or Welsh
- Aged 18 years or above
- Diagnosed with aortic stenosis (including bioprosthetic valve dysfunction)
- Planned TAVI
- Participant is suitable for treatment with the cerebral embolic protection device in the opinion of the treating physician.
PROTECT-TAVI is a collaboration between University of Oxford and London School of Hygiene & Tropical Medicine.
Professor Rajesh Kharbanda
Senior Manager of the Clinical Trials Unit
Senior Trial Manager
Senior Data Manager
Laura Van Dyck
BHF PROTECT-TAVI Trial Protocol
View the BHF PROTECT-TAVI Trial Protocol.
BHF PROTECT-TAVI Summary Trial Protocol
View the BHF PROTECT-TAVI Summary Trial Protocol.
BHF PROTECT-TAVI Participant Information Sheet
BHF PROTECT-TAVI Consent Form
Download the BHF PROTECT-TAVI Consent Form.
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