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

British Heart Foundation Randomised Trial of Routine Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (BHF PROTECT-TAVI) 

BHF PROTECT-TAVI 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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About

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. 

Resources

All the study documentation for the trial can be found here.

About
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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
  • 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.
Who we are

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

BHF PROTECT-TAVI profiles

Professor Rajesh Kharbanda

Chief Investigator

Tim
Clayton

Professor

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

Faran Dhaliwal

Trial Assistant

Zahra Jamal

Trial Assistant
Resources
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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

Read the BHF PROTECT-TAVI Participant Information Sheet.

BHF PROTECT-TAVI Consent Form

Download the BHF PROTECT-TAVI Consent Form.

 

Training Materials
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Read the Sentinel Quick Reference Guide. Users are required to create an account to access the Educare platform.

Publications
Publications
Please check this page at a later date for publications
Newsletters
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Please check this page at a later date for newsletters.