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Pilot Study of Cognitive and Functional Outcomes Following TAVI

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02089945
First received: March 14, 2014
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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
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 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
transcatheter aortic valve implantation
This study recruits individuals that are undergoing transcatheter aortic valve implantation.

  Eligibility

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

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
  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

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Not yet 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
Investigators
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: March 26, 2014
Health Authority: Canada: Ethics Review Committee

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
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on November 25, 2014