An observational study in Aortic Valve Disease, sponsored by Brighton and Sussex University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Brighton and Sussex University Hospitals NHS Trust · Observational
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.
234 studies on the registry are indexed under Aortic Valve Disease; 70 are open to participants now.
This study's enrollment of 120 is below the median of 200 across 106 observational studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Brighton and Sussex University Hospitals NHS Trust is the lead sponsor of 22 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be selected from those undergoing Transcatheter Aortic Valve Implantation at the Royal Sussex County Hospital, Brighton, United Kingdom.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomised in the BHF PROTECT study to TAVI without Sentinel cerebral embolic protection
Patients randomised in the BHF PROTECT study to TAVI with Sentinel cerebral embolic protection
Neurocognitive change
Neurocognitive change by individual scores for each task performed
Time frame: <3 days post-TAVI
Neurocognitive change
Neurocognitive change by individual scores for each task performed
Time frame: 12-months post-TAVI
Subgroup interactions
Age, baseline cognitive score, prior CVA, type of TAVI device, procedural pre- and post-dilation
Time frame: <3 days post-TAVI
Plan to share: Undecided — Pending based on BHF PROTECT study
No publications or documents are linked to this record.
Ran from May 2021 to primary completion in Jun 2022, 12 months.
Of 47 non-industry observational studies under Aortic Valve Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 147. This study's 12 months is below that.
Counting every sponsor, half of 56 studies reached it within 49 months; a quarter within 23 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Brighton and Sussex University Hospitals NHS Trust