Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement

NCT ID: NCT02971020

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-03-21

Brief Summary

The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.

Detailed Description

The investigators are conducting a pilot study to compare cognitive outcomes in up to 60 Veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) at the Minneapolis VA Health Care System. Participants will be administered a short battery of cognitive tests before and three months after TAVR or SAVR over/up to a two year study period.

Conditions

Cardiovascular Disease; Aortic Valve Stenosis; Cognitive Assessments; Valve Surgery; Transcatheter Valve Replacement; Surgical Valve Replacement

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Surgical Aortic Valve Replacement

Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).

Group Type: OTHER

Observational/Cognitive Assessment

Intervention Type: OTHER

Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).

Transcatheter Aortic Valve Replacement

Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).

Group Type: OTHER

Observational/Cognitive Assessment

Intervention Type: OTHER

Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).

Interventions

Observational/Cognitive Assessment

Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Severe aortic stenosis (AVA: 1 cm2 and/or mean gradient =or > 40 mmHg and/or peak velocity > 4 m/s)
• Scheduled to undergo either surgical or transcatheter aortic valve replacement at the Minneapolis VA Health Care System

Exclusion Criteria

• Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures)
• Unable or unwilling to provide informed consent

• Maximum Eligible Age: 104 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

Minnesota Veterans Medical Research and Education Foundation

OTHER

Sponsor Role: lead

Responsible Party

Santiago Garcia

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Santiago Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Howard Fink, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Locations

Minneapolis VA Health Care System

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

4588-A

Identifier Type: -

Identifier Source: org_study_id