Pilot Study of Cognitive and Functional Outcomes Following TAVI

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
First received: March 14, 2014
Last updated: November 26, 2015
Last verified: November 2015
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.

Aortic Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive and Functional Outcomes Following Transcatheter Aortic Valve Implantation (TAVI): a Pilot Study

Resource links provided by NLM:

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Cognitive performance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Functional capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Timed Up and Go Test (TUG) and Hand Grip Strength Test

Other Outcome Measures:
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Minnesota Living with Heart Failure Questionnaire (MLHFQ) and EQ-5D-5L questionnaires

  • Depression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Centre for Epidemiologic Studies Depression Scale (CES-D)

  • Apathy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Apathy Evaluation Scale (AES)

Estimated Enrollment: 31
Study Start Date: March 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
transcatheter aortic valve implantation
This study recruits individuals that are undergoing transcatheter aortic valve implantation.

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.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of severe symptomatic aortic stenosis (aortic valve area < 1 cm2, mean gradient across the aortic valve of 40 mm Hg or more and a peak aortic jet velocity of 4.0 m/s or more) undergoing transcatheter aortic valve implantation

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089945

Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Krista L Lanctot, PhD    4164806100 ext 2241    krista.lanctot@sunnybrook.ca   
Principal Investigator: Krista L Lanctot, PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Principal Investigator: Krista L Lanctot, PhD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02089945     History of Changes
Other Study ID Numbers: 503-2013 
Study First Received: March 14, 2014
Last Updated: November 26, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
transcatheter aortic valve implantation
severe aortic stenosis
functional capacity
quality of life

Additional relevant MeSH terms:
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on February 11, 2016