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Pilot Study of Cognitive and Functional Outcomes Following TAVI

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02089945
Collaborator
(none)
14
Enrollment
1
Location
19
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    14 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cognitive and Functional Outcomes Following Transcatheter Aortic Valve Implantation (TAVI): a Pilot Study
    Study Start Date :
    Feb 1, 2014
    Actual Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Sep 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    transcatheter aortic valve implantation

    This study recruits individuals that are undergoing transcatheter aortic valve implantation.

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive performance [6 months]

      The 30-minute neuropsychiatric assessment battery recommended by NINDS-CSN (National Institute of Neurological Disorders and Stroke- Canadian Stroke Network) harmonized standards

    Secondary Outcome Measures

    1. Functional capacity [6 months]

      The Timed Up and Go Test (TUG) and Hand Grip Strength Test

    Other Outcome Measures

    1. Quality of life [6 months]

      The Minnesota Living with Heart Failure Questionnaire (MLHFQ) and EQ-5D-5L questionnaires

    2. Depression [6 months]

      Centre for Epidemiologic Studies Depression Scale (CES-D)

    3. Apathy [6 months]

      Apathy Evaluation Scale (AES)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre

    Investigators

    • Principal Investigator: Krista L Lanctot, PhD, Sunnybrook Health Sciences Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT02089945
    Other Study ID Numbers:
    • 503-2013
    First Posted:
    Mar 18, 2014
    Last Update Posted:
    Oct 17, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Sunnybrook Health Sciences Centre
    transcatheter aortic valve implantation
    severe aortic stenosis
    cognition
    functional capacity
    quality of life
    Additional relevant MeSH terms:
    Aortic Valve Stenosis

    Study Results

    No Results Posted as of Oct 17, 2016