Brief Title
Pilot Study of Cognitive and Functional Outcomes Following TAVI
Official Title
Cognitive and Functional Outcomes Following Transcatheter Aortic Valve Implantation (TAVI): a Pilot Study
Brief Summary
Narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede blood delivery and is associated with poor quality of life and death. In the elderly with considerable medical burden, a relatively new non-invasive valve replacement technique called Transcatheter Aortic Valve Implantation (TAVI) can be used instead of open-heart surgery. However, long term changes in cognition after TAVI remain unclear and previous studies have suggested an increased risk of cognitive decline in patients following the surgical procedure. In this pilot study, the investigators will characterize changes in cognition, physical capacity, overall quality of life and neuropsychiatric symptoms (depression and apathy) over 6 months after TAVI.
Detailed Description
Cardiovascular disease including valvular heart disease, contributes to an estimated 36% of all deaths over the age of 70. In particular, severe aortic stenosis is the most common valvular heart disease in the elderly in the Western world and is associated with reduced quality of life and increased mortality. TAVI has been shown to improve survival, with an all-cause mortality at 1 year similar to surgical aortic valve replacement (SAVR) with favourable outcomes long-term including improved functional capacity and quality of life. Recent evidence from randomized controlled trials suggests an increased risk of neurological events (e.g. cognitive decline) up to 1 year after TAVI in comparison to both SAVR and medical treatment. Studies have shown no change in short-term memory, working memory, verbal learning, delayed recognition and verbal fluency 3 months after TAVI. In addition, patients with severe aortic stenosis have an increased risk of mortality and future health complications. This study will be an observational, prospective cohort pilot study to examine changes in cognitive performance and functional outcomes after TAVI. We propose to recruit 34 patients for this study. Cognitive performance will be measured using a standardized cognitive battery prior to TAVI and 6 months post-TAVI. Functional capacity, changes in neuropsychiatric symptoms and quality of life will also be assessed prior to TAVI and 6 months post-TAVI. We hypothesize there will a change in cognitive performance, functional capacity, mood outcomes and quality of life over 6 months after TAVI.
Study Type
Observational
Primary Outcome
Cognitive performance
Secondary Outcome
Functional capacity
Condition
Aortic Stenosis
Study Arms / Comparison Groups
transcatheter aortic valve implantation
Description: This study recruits individuals that are undergoing transcatheter aortic valve implantation.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
14
Start Date
February 2014
Completion Date
September 2015
Primary Completion Date
September 2015
Eligibility Criteria
Inclusion Criteria: - diagnosis of severe symptomatic aortic stenosis - undergoing TAVI - speak and understand English Exclusion Criteria: - emergency TAVI - any medical conditions that will affect their ability to complete the protocol
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Krista L Lanctot, PhD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02089945
Organization ID
503-2013
Responsible Party
Sponsor
Study Sponsor
Sunnybrook Health Sciences Centre
Study Sponsor
Krista L Lanctot, PhD, Principal Investigator, Sunnybrook Health Sciences Centre
Verification Date
October 2016