Pilot Study of Cognitive and Functional Outcomes Following TAVI

NCT02089945 | Completed

• 1 other identifier: 503-2013
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Keywords

transcatheter aortic valve implantation; severe aortic stenosis; cognition; functional capacity; quality of life

Outcome Measures

Primary Outcomes (1)

• Cognitive performance

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

  6 months

Secondary Outcomes (1)

• Functional capacity

  6 months

Other Outcomes (3)

• Quality of life

  6 months

• Depression

  6 months

• Apathy

  6 months

Study Arms (1)

transcatheter aortic valve implantation

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• diagnosis of severe symptomatic aortic stenosis
• undergoing TAVI
• speak and understand English

You may not qualify if:

• emergency TAVI
• any medical conditions that will affect their ability to complete the protocol

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Krista L Lanctot, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 18, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

CA (1)