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Schematic of a CEP device, left, and nurse with patient, right


BHF PROTECT-TAVI (British Heart Foundation Randomised Trial of Routine Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation) is a research study examining the effect of cerebral embolic protection devices on the risk of stroke in patients undergoing Transcatheter Aortic Valve Implantation for aortic stenosis. 

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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.

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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.

Eligibility criteria

The target population for this trial is patients with severe aortic stenosis undergoing treatment by TAVI.

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the trial
  • Aged 18 years or above
  • Considered to be candidates for TAVI by the clinical team (via any access route where CEP may be used)
  • Participant is suitable for treatment with the cerebral embolic protection device in the opinion of the treating physician
Who we are

PROTECT-TAVI is a collaboration between University of Oxford and London School of Hygiene & Tropical Medicine.


Rajesh Kharbanda

Professor / Chief Investigator


Principle Investigator

James Kennedy

Richard Evans

Senior Manager of the Clinical Trials Unit

Alexander Perkins

Senior Trial Manager

Steven Robertson

Senior Data Manager

Laura Van Dyck

Data Manager


Trial Assistant

Zahra Jamal

Trial Assistant

Kiran Bal

Assistant Trial Manager
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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

Read the BHF PROTECT-TAVI Participant Information Sheet.


Download the BHF PROTECT-TAVI Consent Form.


Training for sites
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Randomisation System

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Please check this page at a later date for publications
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Please see below for our e-bulletins.

Recruitment update
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Total number of participants randomised: 

1358 (Updated 12/11/2021)


Site name

No. randomised 08/11/21 - 12/11/21

Total no. randomised Average no. per month
Basildon University Hospital 3 32 4
Blackpool Victoria Hospital 2 3 1
Derriford Hospital, Plymouth 0 22 3
Golden Jubilee Hospital  1 7 1
John Radcliffe Hospital, Oxford 5 274 20
King's College Hospital, London 0 52 6
Leeds General Infirmary 6 276 22
Liverpool Heart and Chest Hospital 2 66 9
Morriston Hospital, Swansea 2 11 1
New Cross Hospital, Wolverhampton 3 108 9
Royal Infirmary of Edinburgh 1 20 2
Royal Papworth Hospital 0 7 3
Royal Sussex County Hospital, Brighton 4 218 17
Royal Victoria Hospital, Belfast 0 21 3
Southampton General Hospital 1 43 8
St Bartholomew's Hospital, London 5 115 13
St George's Hospital 1 2 1
St Thomas' Hospital, London 1 30 4
University Hospital of Wales, Cardiff 0 51 4

 Recruitment graph:

A graph showing the projected recruitment for the trial against the actual recruitment. The graph shows the trial is 10 months ahead of their predicted recruitment target.