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

Minnesota Veterans Medical Research and Education Foundation

Status: Completed

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

Treatments: Other: Observational/Cognitive Assessment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02971020

4588-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: Under 104 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

63 participants in 2 patient groups

Surgical Aortic Valve Replacement

Other group

Description:

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

Treatment:

Other: Observational/Cognitive Assessment

Transcatheter Aortic Valve Replacement

Other group

Description:

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

Treatment:

Other: Observational/Cognitive Assessment