Neurocognitive Assessment in TAVI (NEAT TAVI)

The Influence of Cerebral Protection on Neurocognitive Outcomes Following Transcatheter Aortic Valve Implantation (TAVI)

Severe aortic stenosis is a common heart condition affecting elderly patients. Degeneration of the aortic valve (oneway valve between the heart and the aorta) causes high resistence to blood flow, resulting in strain on the heart and the potential for heart failure and death. Treatment of aortic stenosis has traditionally been with open heart surgery. A new procedure called transcatheter aortic valve implantation (TAVI) allows new aortic valves to be implanted through the femoral arteries, resulting in equivalent outcomes to open surgery with a more rapid recovery. Some complications remain present however, including the risk of debris released during the valve implantation being carried by the blood stream into the brain. This may lead to strokes and a loss of mental capacity. Devices that filter the blood stream and capture this debris have now been developed but are of uncertain benefit. We plan to investigate the brain function of patients who have been randomly assigned to the TAVI procedure with and without the use of filters to see if there are any cognitive benefits to the use of this technology.

Patients who are enrolled in the BHF PROTECT-TAVI trial will be invited to partcipate in this trial. They will have already been randomly assigned to TAVI with or without cerebral filter use. We will perform a series of bedside clinical tests (lasting ~40 minutes) involving questionnaires, pen & paper and computer-based tasks. These will be performed both pre- and post-TAVI. There is no change to routine patient care. Data will be analysed with the assistance of trained neuropsychologists and will provide a valuable insight into the performance and role of the cerebral filter for TAVI patients in the future.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 5BE
      • Royal Sussex County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from those undergoing Transcatheter Aortic Valve Implantation at the Royal Sussex County Hospital, Brighton, United Kingdom.

Description

Inclusion Criteria:

• Randomised in the BHF PROTECT-TAVI trial (assessing stroke outcomes in TAVI with and without filter use).
• Willing to provide informed consent for participation in this trial.

Exclusion Criteria:

• Participant has been excluded from use of the filter device due to anatomical or clinical contra-indications.
• Inadequate English skills.
• Inability to complete assessment tasks due to visual or auditory impairment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control arm; Patients randomised in the BHF PROTECT study to TAVI without Sentinel cerebral embolic protection
Intervention arm; Patients randomised in the BHF PROTECT study to TAVI with Sentinel cerebral embolic protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognitive change	Neurocognitive change by individual scores for each task performed	<3 days post-TAVI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognitive change	Neurocognitive change by individual scores for each task performed	12-months post-TAVI

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subgroup interactions	Age, baseline cognitive score, prior CVA, type of TAVI device, procedural pre- and post-dilation	<3 days post-TAVI

Collaborators and Investigators

• Sponsor: Brighton and Sussex University Hospitals NHS Trust
• Collaborators: Terumo Medical Corporation; University of Melbourne

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: NEAT TAVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Pending based on BHF PROTECT study